Online Articles Directory Sint Maarten: June 2012

Wednesday, 27 June 2012

Klaricid Paediatric Suspension 250mg / 5ml

1. Name Of The Medicinal Product

Klaricid Paediatric Suspension 250mg/5ml or Clarithromycin 250mg/5ml Granules for Oral Suspension

2. Qualitative And Quantitative Composition


Active	mg/5ml
Clarithromycin	250

3. Pharmaceutical Form

White to off - white granules for reconstitution.

4. Clinical Particulars

4.1 Therapeutic Indications

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Klaricid Paediatric Suspension 250mg/5ml or Clarithromycin 250mg/5ml Granules for Oral Suspension is indicated in children 6 months to 12 years.

Klaricid Paediatric Suspension 250mg/5ml or Clarithromycin 250mg/5ml Granules for Oral Suspension is indicated for the treatment of infections caused by susceptible organisms. Indications include:

Lower respiratory tract infections.

Upper respiratory tract infections.

Skin and skin structure infections.

Acute otitis media.

Klaricid Paediatric Suspension 250mg/5ml or Clarithromycin 250mg/5ml Granules for Oral Suspension is usually active against the following organisms in vitro:

Gram-positive Bacteria: Staphylococcus aureus (methicillin susceptible); Streptococcus pyogenes (Group A beta-haemolytic streptococci); alpha-haemolytic streptococci (viridans group); Streptococcus (Diplococcus) pneumoniae; Streptococcus agalactiae; Listeria monocytogenes.

Gram-negative Bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae; Legionella pneumophila, Bordetella pertussis, Helicobacter pylori; Campylobacter jejuni.

Mycoplasma: Mycoplasma pneumoniae; Ureaplasma urealyticum.

Other Organisms: Chlamydia trachomatis; Mycobacterium avium; Mycobacterium leprae; Chlamydia pneumoniae.

Anaerobes: Macrolide-susceptible Bacteroides fragilis; Clostridium perfringens; Peptococcus species; Peptostreptococcus species; Propionibacterium acnes.

Klaricid Paediatric Suspension 250mg/5ml or Clarithromycin 250mg/5ml Granules for Oral Suspension has bactericidal activity against several bacterial strains. These organisms include H. influenzae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae, Helicobacter pylori and Campylobacter species.

The activity of clarithromycin against H. pylori is greater at neutral pH than at acid pH.

4.2 Posology And Method Of Administration

Recommended doses and dosage schedules:

The usual duration of treatment is for 5 to 10 days depending on the pathogen involved and the severity of the condition. The recommended daily dosage of Klaricid Paediatric Suspension 250mg/5ml or Clarithromycin 250mg/5ml Granules for Oral Suspension in children is given in the following table and is based on a 7.5mg/kg b.i.d. dosing regime. Doses up to 500mg b.i.d. have been used in the treatment of severe infections.

KLARICID PAEDIATRIC SUSPENSION 250MG/5ML OR CLARITHROMYCIN 250MG/5ML GRANULES FOR ORAL SUSPENSION

DOSAGE IN CHILDREN

Dosage Based on Body Weight (kg)
Weight * (kg)	Approx Age (yrs)	Dosage twice a day
(ml)	(mg)
8-11	1 - 2	1.25	62.50
12-19	3 - 6	2.5	125.00
20-29	7 - 9	3.75	187.50
30-40	10 - 12	5	250.00

* Children < 8 kg should be dosed on a per kg basis (approx. 7.5 mg/kg twice a day)

Preparation for use:

140 ml bottle: 74ml of water should be added to the granules in the bottle and shaken to yield 140ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 250mg per 5ml.

100 ml bottle: 53ml of water should be added to the granules in the bottle and shaken to yield 100ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 250mg per 5ml.

70 ml bottle: 37ml of water should be added to the granules in the bottle and shaken to yield 70ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 250mg per 5ml.

50 ml bottle: 27ml of water should be added to the granules in the bottle and shaken to yield 50ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 250mg per 5ml.

4.3 Contraindications

Klaricid Paediatric Suspension 250mg/5ml or Clarithromycin 250mg/5ml Granules for Oral Suspension is contra-indicated in patients with known hypersensitivity to macrolide antibiotic drugs or to any of its excipients.

Concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated, as this may result in ergot toxicity.

Concomitant administration of clarithromycin and any of the following drugs is contraindicated: astemizole, cisapride, pimozide and terfenadine as this may result in QT prolongation and cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, and torsades de pointe (see section 4.5).

Clarithromycin should not be given to patients with history of QT prolongation or ventricular cardiac arrhythmia, including torsades de pointe (see sections 4.4 and 4.5).

Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins), lovastatin or simvastatin, due to the risk of rhabdomyolysis. Treatment with these agents should be discontinued during clarithromycin treatment (see section 4.4).

Clarithromycin should not be given to patients with hypokalaemia (risk of prolongation of QT-time).

Clarithromycin should not be used in patients who suffer from severe hepatic failure in combination with renal impairment.

4.4 Special Warnings And Precautions For Use

The physician should not prescribe clarithromycin to pregnant women without carefully weighing the benefits against risk, particularly during the first three months of pregnancy (see section 4.6).

Caution is advised in patients with severe renal insufficiency (see section 4.2).

Clarithromycin is principally excreted by the liver. Therefore, caution should be exercised in administering this antibiotic to patients with impaired hepatic function. Caution should also be exercised when administering clarithromycin to patients with moderate to severe renal impairment.

Cases of fatal hepatic failure (see section 4.8) have been reported. Some patients may have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products. Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop, such as anorexia, jaundice, dark urine, pruritus, or tender abdomen.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including macrolides, and may range in severity from mild to life-threatening. Clostridium difficile- associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents including clarithromycin, and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, which may lead to overgrowth of C. difficile. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. Therefore, discontinuation of clarithromycin therapy should be considered regardless of the indication. Microbial testing should be performed and adequate treatment initiated. Drugs inhibiting peristalsis should be avoided.

Exacerbation of symptoms of myasthenia gravis has been reported in patients receiving clarithromycin therapy.

There have been post-marketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients (see section 4.5). If concomitant administration of colchicine and clarithromycin is necessary, patients should be monitored for clinical symptoms of colchicine toxicity.

Caution is advised regarding concomitant administration of clarithromycin and triazolobenzodiazepines, such as triazolam, and midazolam (see section 4.5).

Caution is advised regarding concomitant administration of clarithromycin with other ototoxic drugs, especially with aminoglycosides. Monitoring of vestibular and auditory function should be carried out during and after treatment.

Due to the risk for QT prolongation, clarithromycin should be used with caution in patients with coronary artery disease, severe cardiac insufficiency, hypomagnesaemia, bradycardia (<50 bpm), or when co-administered with other medicinal products associated with QT prolongation (see section 4.5). Clarithromycin must not be used in patients with congenital or documented acquired QT prolongation or history of ventricular arrhythmia (see section 4.3).

Pneumonia: In view of the emerging resistance of Streptococcus pneumoniae to macrolides, it is important that sensitivity testing be performed when prescribing clarithromycin for community-acquired pneumonia. In hospital-acquired pneumonia, clarithromycin should be used in combination with additional appropriate antibiotics.

Skin and soft tissue infections of mild to moderate severity: These infections are most often caused by Staphylococcus aureus and Streptococcus pyogenes, both of which may be resistant to macrolides. Therefore, it is important that sensitivity testing be performed. In cases where beta–lactam antibiotics cannot be used (e.g. allergy), other antibiotics, such as clindamycin, may be the drug of first choice. Currently, macrolides are only considered to play a role in some skin and soft tissue infections, such as those caused by Corynebacterium minutissimum (erythrasma), acne vulgaris, and erysipelas and in situations where penicillin treatment cannot be used.

In the event of severe acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, clarithromycin therapy should be discontinued immediately and appropriate treatment should be urgently initiated.

Clarithromycin should be used with caution when administered concurrently with medications that induce the cytochrome CYP3A4 enzyme (see section 4.5).

HMG-CoA reductase inhibitors: Concomitant use of clarithromycin with lovastatin or simvastatin is contraindicated (see section 4.3). As with other macrolides, clarithromycin has been reported to increase concentrations of HMG-CoA reductase inhibitors (see section 4.5). Rare reports of rhabdomyolysis have been reported in patients taking these drugs concomitantly. Patients should be monitored for signs and symptoms of myopathy. Rare reports of rhabdomyolysis have also been reported in patients taking atorvastatin or rosuvastatin concomitantly with clarithromycin. When used with clarithromycin, atorvastatin or rosuvastatin should be administered in the lowest possible doses. Adjustment of the statin dose or use of a statin that is not dependent on CYP3A metabolism (e.g. fluvastatin or pravastatin) should be considered.

Oral hypoglycaemic agents/Insulin: The concomitant use of clarithromycin and oral hypoglycaemic agents and/or insulin can result in significant hypoglycaemia. With certain hypoglycaemic drugs such as nateglinide, pioglitazone, repaglinide and rosiglitazone, inhibition of CYP3A enzyme by clarithromycin may be involved and could cause hypoglycaemia when used concomitantly. Careful monitoring of glucose is recommended.

Oral anticoagulants: There is a risk of serious haemorrhage and significant elevations in International Normalized Ratio (INR) and prothrombin time when clarithromycin is co-administered with warfarin (see section 4.5). INR and prothrombin times should be frequently monitored while patients are receiving clarithromycin and oral anticoagulants concurrently.

Use of any antimicrobial therapy, such as clarithromycin, to treat H. pylori infection may select for drug-resistant organisms.

Long-term use may, as with other antibiotics, result in colonisation with increased numbers of non-susceptible bacteria and fungi. If superinfections occur, appropriate therapy should be instituted.

Attention should also be paid to the possibility of cross resistance between clarithromycin and other macrolide drugs, as well as lincomycin and clindamycin.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The use of the following drugs is strictly contraindicated due to the potential for severe drug interaction effects:

Cisapride, pimozide, astemizole and terfenadine:

Elevated cisapride levels have been reported in patients receiving clarithromycin and cisapride concomitantly. This may result in QT prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and torsades de pointes. Similar effects have been observed in patients taking clarithromycin and pimozide concomitantly (see section 4.3).

Macrolides have been reported to alter the metabolism of terfenadine resulting in increased levels of terfenadine which has occasionally been associated with cardiac arrhythmias, such as QT prolongation, ventricular tachycardia, ventricular fibrillation and torsades de pointes (see section 4.3). In one study in 14 healthy volunteers, the concomitant administration of clarithromycin and terfenadine resulted in 2- to 3-fold increase in the serum level of the acid metabolite of terfenadine and in prolongation of the QT interval which did not lead to any clinically detectable effect. Similar effects have been observed with concomitant administration of astemizole and other macrolides.

Ergotamine/dihydroergotamine:

Post-marketing reports indicate that co-administration of clarithromycin with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm, and ischaemia of the extremities and other tissues including the central nervous system. Concomitant administration of clarithromycin and these medicinal products is contraindicated (see section 4.3).

Effects of Other Medicinal Products on Clarithromycin

Drugs that are inducers of CYP3A (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital, St John's wort) may induce the metabolism of clarithromycin. This may result in sub-therapeutic levels of clarithromycin leading to reduced efficacy. Furthermore, it might be necessary to monitor the plasma levels of the CYP3A inducer, which could be increased owing to the inhibition of CYP3A by clarithromycin (see also the relevant product information for the CYP3A4 inhibitor administered). Concomitant administration of rifabutin and clarithromycin resulted in an increase in rifabutin, and decrease in clarithromycin serum levels together with an increased risk of uveitis.

The following drugs are known or suspected to affect circulating concentrations of clarithromycin; clarithromycin dosage adjustment or consideration of alternative treatments may be required.

Efavirenz, nevirapine, rifampicin, rifabutin and rifapentine

Strong inducers of the cytochrome P450 metabolism system such as efavirenz, nevirapine, rifampicin, rifabutin, and rifapentine may accelerate the metabolism of clarithromycin and thus lower the plasma levels of clarithromycin, while increasing those of 14-OH-clarithromycin, a metabolite that is also microbiologically active. Since the microbiological activities of clarithromycin and 14-OH-clarithromycin are different for different bacteria, the intended therapeutic effect could be impaired during concomitant administration of clarithromycin and enzyme inducers.

Fluconazole

Concomitant administration of fluconazole 200 mg daily and clarithromycin 500 mg twice daily to 21 healthy volunteers led to increases in the mean steady-state minimum clarithromycin concentration (Cmin) and area under the curve (AUC) of 33% and 18% respectively. Steady state concentrations of the active metabolite 14-OH-clarithromycin were not significantly affected by concomitant administration of fluconazole. No clarithromycin dose adjustment is necessary.

Ritonavir

A pharmacokinetic study demonstrated that the concomitant administration of ritonavir 200 mg every eight hours and clarithromycin 500 mg every 12 hours resulted in a marked inhibition of the metabolism of clarithromycin. The clarithromycin Cmax increased by 31%, Cmin increased 182% and AUC increased by 77% with concomitant administration of ritonavir. An essentially complete inhibition of the formation of 14-OH-clarithromycin was noted. Because of the large therapeutic window for clarithromycin, no dosage reduction should be necessary in patients with normal renal function. However, for patients with renal impairment, the following dosage adjustments should be considered: For patients with CL_CR 30 to 60 mL/min the dose of clarithromycin should be reduced by 50%. For patients with CL_CR <30 mL/min the dose of clarithromycin should be decreased by 75%. Doses of clarithromycin greater than 1 gm/day should not be co-administered with ritonavir.

Similar dose adjustments should be considered in patients with reduced renal function when ritonavir is used as a pharmacokinetic enhancer with other HIV protease inhibitors including atazanavir and saquinavir (see section below, Bi-directional drug interactions)

Effect of Clarithromycin on Other Medicinal Products

CYP3A-based interactions

Co-administration of clarithromycin, known to inhibit CYP3A, and a drug primarily metabolised by CYP3A may be associated with elevations in drug concentrations that could increase or prolong both therapeutic and adverse effects of the concomitant drug. Clarithromycin should be used with caution in patients receiving treatment with other drugs known to be CYP3A enzyme substrates, especially if the CYP3A substrate has a narrow safety margin (e.g. carbamazepine) and/or the substrate is extensively metabolised by this enzyme.

Dosage adjustments may be considered, and when possible, serum concentrations of drugs primarily metabolised by CYP3A should be monitored closely in patients concurrently receiving clarithromycin.

The following drugs or drug classes are known or suspected to be metabolised by the same CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, ciclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, sirolimus, tacrolimus, terfenadine, triazolam and vinblastine. Drugs interacting by similar mechanisms through other isozymes within the cytochrome P450 system include phenytoin, theophylline and valproate.

Antiarrhythmics

There have been post-marketed reports of torsade de points occurring with the concurrent use of clarithromycin and quinidine or disopyramide. Electrocardiograms should be monitored for QTc prolongation during co-administration of clarithromycin with these drugs. Serum levels of quinidine and disopyramide should be monitored during clarithromycin therapy.

Omeprazole

Clarithromycin (500 mg every 8 hours) was given in combination with omeprazole (40 mg daily) to healthy adult subjects. The steady-state plasma concentrations of omeprazole were increased (C_max, AUC_0-24, and t_1/2 increased by 30%, 89%, and 34%, respectively), by the concomitant administration of clarithromycin. The mean 24-hour gastric pH value was 5.2 when omeprazole was administered alone and 5.7 when omeprazole was co-administered with clarithromycin.

Sildenafil, tadalafil and vardenafil

Each of these phosphodiesterase inhibitors is metabolised, at least in part, by CYP3A, and CYP3A may be inhibited by concomitantly administered clarithromycin. Co-administration of clarithromycin with sildenafil, tadalafil or vardenafil would likely result in increased phosphodiesterase inhibitor exposure. Reduction of sildenafil, tadalafil and vardenafil dosages should be considered when these drugs are co-administered with clarithromycin.

Theophylline, carbamazepine

Results of clinical studies indicate that there was a modest but statistically significant (p

Tolterodine

The primary route of metabolism for tolterodine is via the 2D6 isoform of cytochrome P450 (CYP2D6). However, in a subset of the population devoid of CYP2D6, the identified pathway of metabolism is via CYP3A. In this population subset, inhibition of CYP3A results in significantly higher serum concentrations of tolterodine. A reduction in tolterodine dosage may be necessary in the presence of CYP3A inhibitors, such as clarithromycin in the CYP2D6 poor metaboliser population.

Triazolobenzodiazepines (e.g., alprazolam, midazolam, triazolam)

When midazolam was co-administered with clarithromycin tablets (500 mg twice daily), midazolam AUC was increased 2.7-fold after intravenous administration of midazolam and 7-fold after oral administration. Concomitant administration of oral midazolam and clarithromycin should be avoided. If intravenous midazolam is co-administered with clarithromycin, the patient must be closely monitored to allow dose adjustment. The same precautions should also apply to other benzodiazepines that are metabolised by CYP3A, including triazolam and alprazolam. For benzodiazepines which are not dependent on CYP3A for their elimination (temazepam, nitrazepam, lorazepam), a clinically important interaction with clarithromycin is unlikely.

There have been post-marketing reports of drug interactions and central nervous system (CNS) effects (e.g., somnolence and confusion) with the concomitant use of clarithromycin and triazolam. Monitoring the patient for increased CNS pharmacological effects is suggested.

Other drug interactions

Colchicine

Colchicine is a substrate for both CYP3A and the efflux transporter, P-glycoprotein (Pgp). Clarithromycin and other macrolides are known to inhibit CYP3A and Pgp. When clarithromycin and colchicine are administered together, inhibition of Pgp and/or CYP3A by clarithromycin may lead to increased exposure to colchicine. Patients should be monitored for clinical symptoms of colchicine toxicity (see section 4.4).

Digoxin

Digoxin is thought to be a substrate for the efflux transporter, P-glycoprotein (Pgp). Clarithromycin is known to inhibit Pgp. When clarithromycin and digoxin are administered together, inhibition of Pgp by clarithromycin may lead to increased exposure to digoxin. Elevated digoxin serum concentrations in patients receiving clarithromycin and digoxin concomitantly have also been reported in post marketing surveillance. Some patients have shown clinical signs consistent with digoxin toxicity, including potentially fatal arrhythmias. Serum digoxin concentrations should be carefully monitored while patients are receiving digoxin and clarithromycin simultaneously.

Zidovudine

Simultaneous oral administration of clarithromycin tablets and zidovudine to HIV-infected adult patients may result in decreased steady-state zidovudine concentrations. Because clarithromycin appears to interfere with the absorption of simultaneously administered oral zidovudine, this interaction can be largely avoided by staggering the doses of clarithromycin and zidovudineto allow for a 4-hour interval between each medication. This interaction does not appear to occur in paediatric HIV-infected patients taking clarithromycin suspension with zidovudine or dideoxyinosine. This interaction is unlikely when clarithromycin is administered via intravenous infusion.

Phenytoin and Valproate

There have been spontaneous or published reports of interactions of CYP3A inhibitors, including clarithromycin with drugs not thought to be metabolised by CYP3A (e.g. phenytoin and valproate). Serum level determinations are recommended for these drugs when administered concomitantly with clarithromycin. Increased serum levels have been reported.

Bi-directional drug interactions

Atazanavir

Both clarithromycin and atazanavir are substrates and inhibitors of CYP3A, and there is evidence of a bi-directional drug interaction. Co-administration of clarithromycin (500 mg twice daily) with atazanavir (400 mg once daily) resulted in a 2-fold increase in exposure to clarithromycin and a 70% decrease in exposure to 14-OH-clarithromycin, with a 28% increase in the AUC of atazanavir. Because of the large therapeutic window for clarithromycin, no dosage reduction should be necessary in patients with normal renal function. For patients with moderate renal function (creatinine clearance 30 to 60 mL/min), the dose of clarithromycin should be decreased by 50%. For patients with creatinine clearance <30 mL/min, the dose of clarithromycin should be decreased by 75% using an appropriate clarithromycin formulation. Doses of clarithromycin greater than 1000 mg per day should not be co-administered with protease inhibitors.

Itraconazole

Both clarithromycin and itraconazole are substrates and inhibitors of CYP3A, leading to a bidirectional drug interaction. Clarithromycin may increase the plasma levels of itraconazole, while itraconazole may increase the plasma levels of clarithromycin. Patients taking itraconazole and clarithromycin concomitantly should be monitored closely for signs or symptoms of increased or prolonged pharmacologic effect.

Saquinavir

Both clarithromycin and saquinavir are substrates and inhibitors of CYP3A, and there is evidence of a bi-directional drug interaction. Concomitant administration of clarithromycin (500 mg twice daily) and saquinavir (soft gelatin capsules, 1200 mg three times daily) to 12 healthy volunteers resulted in steady-state AUC and C_max values of saquinavir which were 177% and 187% higher than those seen with saquinavir alone. Clarithromycin AUC and C_max values were approximately 40% higher than those seen with clarithromycin alone. No dose adjustment is required when the two drugs are co-administered for a limited time at the doses/formulations studied. Observations from drug interaction studies using the soft gelatin capsule formulation may not be representative of the effects seen using the saquinavir hard gelatin capsule. Observations from drug interaction studies performed with saquinavir alone may not be representative of the effects seen with saquinavir/ritonavir therapy. When saquinavir is co-administered with ritonavir, consideration should be given to the potential effects of ritonavir on clarithromycin.

Verapamil

Hypotension, bradyarrhythmias and lactic acidosis have been observed in patients taking clarithromycin and verapamil concomitantly.

4.6 Pregnancy And Lactation

The safety of clarithromycin during pregnancy and breast feeding of infants has not been established. Based on variable results obtained from studies in mice, rats, rabbits and monkeys, the possibility of adverse effects on embryofoetal development cannot be excluded. Therefore, use during pregnancy is not advised without carefully weighing the benefits against risk. Clarithromycin is excreted into human breast milk.

4.7 Effects On Ability To Drive And Use Machines

There are no data on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should be taken into account before patients drive or use machines.

4.8 Undesirable Effects

a. Summary of the safety profile

The most frequent and common adverse reactions related to clarithromycin therapy for both adult and peadiatric populations are abdominal pain, diarrhoea, nausea, vomiting and taste perversion. These adverse reactions are usually mild in intensity and are consistent with the known safety profile of macrolide antibiotics (see section b of section 4.8).

There was no significant difference in the incidence of these gastrointestinal adverse reactions during clinical trials between the patient population with or without pre-existing mycobacterial infections.

b. Tabulated summary of adverse reactions

The following table displays adverse reactions reported in clinical trials and from post-marketing experience with clarithromycin immediate-release tablets, granules for oral suspension, powder for solution for injection, extended-release tablets and modified-release tablets.

The reactions considered at least possibly related to clarithromycin are displayed by system organ class and frequency using the following convention: very common (

System Organ Class	Very common	Common	Uncommon	Not Known (cannot be estimated from the available data)
Infections and infestations			Cellulitis¹, candidiasis, gastroenteritis², infection³, vaginal infection	Pseudomembranous colitis, erysipelas, erythrasma
Blood and lymphatic system			Leukopenia, neutropenia⁴, thrombocythaemia³, eosinophilia⁴	Agranulocytosis, thrombocytopenia
Immune system disorders⁵			Anaphylactoid reaction¹, hypersensitivity	Anaphylactic reaction
Metabolism and nutrition disorders			Anorexia, decreased appetite	Hypoglycaemia⁶
Psychiatric disorders		Insomnia	Anxiety, nervousness³, screaming³	Psychotic disorder, confusional state, depersonalisation, depression, disorientation, hallucination, abnormal dreams
Nervous system disorders		Dysgeusia, headache, taste perversion	Loss of consciousness¹, dyskinesia¹, dizziness, somnolence⁷, tremor	Convulsion, ageusia, parosmia, anosmia
Ear and labyrinth disorders			Vertigo, hearing impaired, tinnitus	Deafness
Cardiac disorders			Cardiac arrest¹, atrial fibrillation¹, electrocardiogram QT prolonged⁸, extrasystoles¹, palpitations	Torsade de pointes⁸, ventricular tachycardia⁸
Vascular disorders		Vasodilation¹		Haemorrhage⁹
Respiratory, thoracic and mediastinal disorder			Asthma¹, epistaxis², pulmonary embolism¹
Gastrointestinal disorders		Diarrhoea¹⁰, vomiting, dyspepsia, nausea, abdominal pain	Oesophagitis¹, gastrooesophageal reflux disease², gastritis, proctalgia², stomatitis, glossitis, abdominal distension⁴, constipation, dry mouth, eructation, flatulence,	Pancreatitis acute, tongue discolouration, tooth discolouration
Hepatobiliary disorders		Liver function test abnormal	Cholestasis⁴, hepatitis⁴, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased⁴	Hepatic failure¹¹, jaundice hepatocellular
Skin and subcutaneous tissue disorders		Rash, hyperhidrosis	Dermatitis bullous¹, pruritus, urticaria, rash maculo-papular³	Stevens-Johnson syndrome⁵, toxic epidermal necrolysis⁵, drug rash with eosinophilia and systemic symptoms (DRESS), acne
Musculoskeletal and connective tissue disorders			Muscle spasms³, musculoskeletal stiffness¹, myalgia²	Rhabdomyolysis^2,12, myopathy
Renal and urinary disorders			Blood creatinine increased¹, blood urea increased¹	Renal failure, nephritis interstitial
General disorders and administration site conditions	Injection site phlebitis¹	Injection site pain¹, injection site inflammation¹	Malaise⁴, pyrexia³, asthenia, chest pain⁴, chills⁴, fatigue⁴
Investigations			Albumin globulin ratio abnormal¹, blood alkaline phosphatase increased⁴, blood lactate dehydrogenase increased⁴	International normalised ratio increased⁹, prothrombin time prolonged⁹, urine color abnormal

¹ ADRs reported only for the Powder for Solution for Injection formulation

²ADRs reported only for the Extended-Release Tablets formulation

³ ADRs reported only for the Granules for Oral Suspension formulation

⁴ ADRs reported only for the Immediate-Release Tablets formulation

^5,8,10,11,12See section a)

^6,7,9See section c)

c. Description of selected adverse reactions

Injection site phlebitis, injection site pain, vessel puncture site pain, and injection site inflammation are specific to the clarithromycin intravenous formulation.

In very rare instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases and/or concomitant medications (see section 4.4).

A special attention to diarrhoea should be paid as Clostridium difficile-associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents including clarithromycin, and may range in severity from mild diarrhoea to fatal colitis. (see section 4.4)

In the event of severe acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson Syndrome and toxic epidermal necrolysis, clarithromycin therapy should be discontinued immediately and appropriate treatment should be urgently initiated (see section 4.4).

As with other macrolides, QT prolongation, ventricular tachycardia, and torsade de pointes have rarely been reported with clarithromycin (see section 4.4 and 4.5).

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clarithromycin, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents (see section 4.4).

In some of the reports of rhabdomyolysis, clarithromycin was administered concomitantly with statins, fibrates, colchicine or allopurinol (see section 4.3 and 4.4).

There have been post-marketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in elderly and/or patients with renal insufficiency, some with a fatal outcome. (see sections 4.4 and 4.5).

There have been rare reports of hypoglycaemia, some of which have occurred in patients on concomitant oral hypoglycaemic agents or insulin (see section 4.4 and 4.5).

There have been post-marketing reports of drug interactions and central nervous system (CNS) effects (e.g. somnolence and confusion) with the concomitant use of clarithromycin and triazolam. Monitoring the patient for increased CNS pharmacological effects is suggested (see section 4.5).

There is a risk of serious haemorrhage and significant elevations in INR and prothrombin time when clarithromycin is co-administered with warfarin. INR and prothrombin times should be frequently monitored while patients are receiving clarithromycin and oral anticoagulants concurrently (see section 4.4 and 4.5).

There have been rare reports of clarithromycin ER tablets

Acarexx

Dosage Form: FOR ANIMAL USE ONLY
Acarexx®

(0.01% ivermectin)

Otic Suspension

NADA 141-174, Approved by FDA

Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description

Chemical name: Ivermectin is a mixture of 5-O-demethyl-22,23-dihydroavermectin A1a (component B1a) and 5-O-demethyl-25-de (1-methylpropyl)-22,23-dihydro-25-(1-methylethyl) avermectin A1b (component B1b). Empirical formula: B1a = C48H74O14, B1b = C47H72O14. Molecular weight: B1a = 875.10, B1b = 861.07.

Indications

Acarexx (0.01% ivermectin) Otic Suspension is indicated for the treatment of adult ear mite (Otodectes cynotis) infestations in cats and kittens four weeks of age or older. Effectiveness against eggs and immature stages has not been proven.

Dosage

Acarexx suspension is administered topically in the ear canal at an ivermectin concentration of 0.01%. One dose of 0.5 mL is applied in each ear. Repeat treatment one time if necessary, based upon the ear mite life cycle and the response to treatment.

Administration

Tear foil pouch at the notch to remove the two plastic ampules. Use one ampule per ear. Shake well before use. Snap off the cap of the ampule and place the tip into the external ear canal. Squeeze the entire contents of one ampule into the ear and massage the base of the ear to distribute the medication. Repeat the procedure in the other ear using the second ampule. In clinical field trials, ears were not cleaned and many animals still had debris in their ears at the end of the study. Cleaning the ears prior to administration of Acarexx suspension is not necessary to provide effectiveness.

Human Warnings

Not for human use. Keep out of reach of children.

Precautions

The safe use of Acarexx suspension in cats used for breeding purposes, during pregnancy, or in lactating queens, has not been evaluated.

Adverse Reactions

In approximately 1% of 80 cats and kittens, pain associated with the pinna and vomiting were observed following treatment with Acarexx suspension.

To report suspected adverse reactions, to obtain a Material Safety Data Sheet or for technical assistance, call 1-866-638-2226.

Effectiveness

One treatment with Acarexx suspension was 92% effective in treating adult ear mite (Otodectes cynotis) infestations after seven days in a dose titration/confirmation study. In a well-controlled clinical field trial, one treatment of Acarexx suspension was 94% effective in clearing cats and kittens of adult ear mite infestations within 7 to 10 days.

Safety

In two Target Animal Safety studies, Acarexx suspension was proven to be safe in kittens four weeks of age or older. Four-week-old kittens were administered Acarexx suspension at dose rates of 1X, 3X and 5X the recommended dose for three or six consecutive days and no adverse reactions were observed, except one kitten treated at 1X the dose had histologic evidence of minimal, chronic dermal inflammation of the ear. In a well-controlled clinical field trial, Acarexx suspension was used safely in cats and kittens receiving other frequently used veterinary products such as flea control products, vaccines, anthelmintics, antibiotics and steroids.

Storage

Store below 86°F (30°C). Protect from freezing.

How Supplied

Acarexx Otic Suspension is packaged in two polypropylene ampules per foil pouch, which are packaged 12 foil pouches per display carton. Each ampule is filled to deliver 0.5 mL of 0.01% ivermectin otic suspension per ear.

Manufactured for:

Boehringer Ingelheim Vetmedica, Inc.

St. Joseph, MO 64506 U.S.A.

Acarexx is a registered trademark of Boehringer Ingelheim Vetmedica, Inc.

449701L-00-1002

Code 449711

Revised 02/10

Laminate Pouch - Front side

Laminate Pouch - Back side

Carton 12 x 2 ampules

Acarexx
ivermectin suspension

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	0010-4497
Route of Administration	AURICULAR (OTIC)	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IVERMECTIN (IVERMECTIN)	IVERMECTIN	0.1 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0010-4497-02	12 POUCH In 1 CARTON	contains a POUCH (0010-4497-01)
1	0010-4497-01	2 AMPULE In 1 POUCH	This package is contained within the CARTON (0010-4497-02) and contains a AMPULE
1		0.5 mL In 1 AMPULE	This package is contained within a POUCH (0010-4497-01) and a CARTON (0010-4497-02)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141174	05/28/2010

Labeler - Boehringer Ingelheim Vetmedica, Inc. (007134091)

Registrant - Boehringer Ingelheim Vetmedica, Inc. (007134091)

Establishment
Name	Address	ID/FEI	Operations
AAI Pharma Services Corp		832394733	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Lancaster Laboratories, Inc.		069777290	ANALYSIS

Revised: 11/2010Boehringer Ingelheim Vetmedica, Inc.

Tuesday, 26 June 2012

Somatuline Depot

Generic Name: lanreotide (Subcutaneous route)

lan-REE-oh-tide

Commonly used brand name(s)

In the U.S.

Somatuline Depot

Available Dosage Forms:

Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Somatostatin (class)

Uses For Somatuline Depot

Lanreotide is used for the long-term treatment of acromegaly (a growth hormone disorder) in patients who cannot be treated with surgery or radiation. This medicine works by reducing the amount of growth hormone that the body produces .

This medicine is available only with your doctor's prescription .

Before Using Somatuline Depot

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lanreotide in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of lanreotide in the elderly. However, elderly patients are more likely to have age-related kidney problems or liver problems, which may require an adjustment in the dose for patients receiving lanreotide .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Cyclosporine

Quinidine

Terfenadine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Somatuline Depot

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin .

Precautions While Using Somatuline Depot

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

This medicine may cause your blood sugar levels to rise or fall. Also, this medicine may cover up signs of hypoglycemia (low blood sugar), such as a change in your pulse rate. If you notice a change in the results of your blood sugar test or urine sugar test, check with your doctor .

Tell your doctor if you are allergic to rubber or latex. The needle cover of the prefilled syringe contains natural dry rubber, which may cause an allergic reaction if you have a latex allergy .

Somatuline Depot Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Abdominal fullness

blurred vision

chest pain or discomfort

dizziness

gaseous abdominal pain

headache

lightheadedness, dizziness, or fainting

nervousness

pale skin

pounding in the ears

recurrent fever

shortness of breath

slow, fast, or irregular heartbeat

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bloated, full feeling

diarrhea

difficulty having a bowel movement (stool)

difficulty with moving

excess air or gas in stomach or intestines

inflammation, itching, lumps, or pain at the injection site

muscle pain or stiffness

nausea

pain in joints

passing gas

stomach pain

vomiting

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Somatuline Depot side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Somatuline Depot resources

Somatuline Depot Side Effects (in more detail)
Somatuline Depot Use in Pregnancy & Breastfeeding
Somatuline Depot Drug Interactions
Somatuline Depot Support Group
0 Reviews for Somatuline Depot - Add your own review/rating

Somatuline Depot Prescribing Information (FDA)

Somatuline Depot Monograph (AHFS DI)

Somatuline Depot MedFacts Consumer Leaflet (Wolters Kluwer)

Somatuline Depot Consumer Overview

Compare Somatuline Depot with other medications

Acromegaly

sulfacetamide sodium topical

Generic Name: sulfacetamide sodium topical (SUL fa SEET a mide SOE dee um TOP i kal)

Brand Names: Klaron, Mexar, Ovace, Ovace Plus, RE 10, Seb-Prev, Sebizon

What is sulfacetamide sodium topical?

Sulfacetamide sodium is an antibiotic that fights bacteria on the skin.

Sulfacetamide sodium topical (for the skin) is used to treat acne, dandruff, seborrheic dermatitis (red, flaking skin rash), and certain skin infections.

Sulfacetamide sodium topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about sulfacetamide sodium topical?

You should not use this medication if you are allergic to sulfacetamide sodium or sulfa drugs.

Before using this medication, tell your doctor if you have asthma or a sulfite allergy, or if you are also using silver sulfadiazine (Silvadene, Thermazene).

Do not use sulfacetamide sodium topical over large skin areas.

Stop using this medication and call your doctor if your symptoms do not improve or if they get worse during treatment.

Avoid getting this medication in your nose, mouth, or eyes. Stop using sulfacetamide sodium topical and call your doctor at once if you have any type of skin rash (mild or severe), joint pain or swelling, fever or sore throat, mouth sores, pale skin, easy bruising or bleeding, unusual weakness, a new or worsening infection, or stomach pain with loss of appetite, dark urine, clay-colored stools, and jaundice (yellowing of the skin or eyes).

What should I discuss with my healthcare provider before using sulfacetamide sodium topical?

You should not use this medication if you are allergic to sulfacetamide sodium or sulfa drugs.

To make sure you can safely use sulfacetamide sodium topical, tell your doctor if you have asthma or a sulfite allergy.

FDA pregnancy category C. It is not known whether sulfacetamide sodium topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether sulfacetamide sodium topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child younger than 12 years old.

How should I use sulfacetamide sodium topical?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Make sure the treatment area is clean and dry before using sulfacetamide sodium topical cream, gel, lotion, or solution. Apply the medication in a thin layer and rub in gently.

You may need to shake the medication before each use. Follow the directions on your medicine label.

To use sulfacetamide sodium soap, wet the skin and apply enough of the medication to work into a lather. Massage the lather on the skin gently and then rinse thoroughly with plain water. Pat the skin dry with a clean towel.

Do not apply sulfacetamide sodium topical over large skin areas. Wash your hands after applying this medication.

If you are using this medication on your scalp, wash your hair with a non-medicated shampoo at least once per week during treatment.

Sulfacetamide sodium topical is usually applied 2 times per day for 8 to 10 days. Space your doses evenly by applying the medication at the same times each day.

You may need to keep using the medication once or twice per week, or once every other week. Follow your doctor's instructions. Call your doctor if your condition comes back after you stop using sulfacetamide sodium topical.

Stop using this medication and call your doctor if your symptoms do not improve or if they get worse during treatment.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea and vomiting, blood in your urine, or urinating less than usual.

What should I avoid while using sulfacetamide sodium topical?

Do not use this medication for any skin infection that has not been checked by a doctor. Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use the medication on sunburned, windburned, dry, chapped, irritated, or broken skin. Avoid getting sulfacetamide sodium topical soap on your eyelids or lips while washing with it.

Avoid getting this medication on your clothing. Sulfacetamide sodium topical may leave a slight yellow color on light fabrics.

Avoid exposure to sunlight or tanning beds. Sulfacetamide sodium topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using other medications on the areas you treat with sulfacetamide sodium topical unless you doctor tells you to.

Sulfacetamide sodium topical side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

patchy skin color, red spots, a butterfly-shaped skin rash over your cheeks and nose;

the first sign of any skin rash, no matter how mild;

joint pain, swelling, or stiffness;

signs of infection such as fever, sore throat, mouth sores, unusual weakness;

pale skin, easy bruising or bleeding;

new or worsening skin infection; or

nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

mild swelling, itching, or redness of treated skin;

dry skin; or

yellow discoloration of treated skin (may be a sign that you have applied too much of the medication).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sulfacetamide sodium topical Dosing Information

Usual Adult Dose for Seborrheic Dermatitis:

Sodium sulfacetamide 10% topical cream and gel: Apply topically to affected areas twice daily (morning and evening) for 8 to 10 days. As conditions subsides, the interval between applications may be lengthened. Use 1 to 2 times weekly or every other week may prevent reoccurances. If condition recurs, reinitiate treatment.

Usual Adult Dose for Secondary Cutaneous Bacterial Infections:

Sodium sulfacetamide 10% topical cream and gel: Apply topically to affected areas twice daily for 8 to 10 days.

Usual Pediatric Dose for Seborrheic Dermatitis:

>=12 yrs: Sodium sulfacetamide 10% topical cream and gel: Apply topically to affected areas twice daily (morning and evening) for 8 to 10 days. As conditions subsides, the interval between applications may be lengthened. Use 1 to 2 times weekly or every other week may prevent reoccurances. If condition recurs, reinitiate treatment.

Usual Pediatric Dose for Secondary Cutaneous Bacterial Infections:

>=12 yrs: Sodium sulfacetamide 10% topical cream and gel: Apply topically to affected areas twice daily for 8 to 10 days.

What other drugs will affect sulfacetamide sodium topical?

Tell your doctor about all other medications you use, especially silver sulfadiazine (Silvadene, Thermazene, and others).

This list is not complete and other drugs may interact with sulfacetamide sodium topical. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Compare sulfacetamide sodium topical with other medications

Seborrheic Dermatitis
Secondary Cutaneous Bacterial Infections

Where can I get more information?

Your pharmacist can provide more information about sulfacetamide sodium topical.

Monday, 25 June 2012

pyrvinium

pir-VIN-ee-um

Uses For pyrvinium

Pyrvinium is used to treat pinworms (enterobiasis). It will not work for other types of worm infections (for example, roundworms or tapeworms).

Pyrvinium is available only with your doctor's prescription.

Before Using pyrvinium

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pyrvinium, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pyrvinium or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Pyrvinium has been studied in children and, in effective doses, has not been reported to cause different side effects or problems in children than it does in adults. However, because of limited experience, caution is recommended in children weighing less than 10 kilograms (22 pounds). Older children are more likely to have stomach upset after receiving large doses.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of pyrvinium in the elderly with use in other age groups, pyrvinium is not expected to cause different side effects or problems in older people than it does in younger adults.

Breast Feeding

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Proper Use of pyrvinium

No special preparations (for example, special diets, fasting, other medicines, laxatives, or enemas) are necessary before, during, or immediately after you take pyrvinium.

Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Pinworms may be easily passed from one person to another, especially among persons in the same household. Therefore, all household members may have to be treated at the same time to prevent their infection or reinfection. Also, all household members may have to be treated again in 2 to 3 weeks to clear up the infection completely. Make sure each family member takes the correct amount, since the dose may be different for each person.

To help clear up your infection completely, take pyrvinium exactly as directed by your doctor. Read the instructions on the label and follow them carefully. The amount of medicine you need is based on your weight. You must take the exact amount if the medicine is going to work. A second course of pyrvinium is usually required to clear up the infection completely.

Dosing

The dose of pyrvinium will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pyrvinium. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For the oral suspension dosage form:
- Adults and children: Dose is based on body weight and will be determined by your doctor. It is taken as a single dose and is repeated in 2 to 3 weeks.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using pyrvinium

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Pyrvinium may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. For a day or two after taking pyrvinium:

Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.

Wear protective clothing, including a hat. Also, wear sunglasses.

Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.

Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.

Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

In some patients, pinworms may return after treatment with pyrvinium. Washing (not shaking) all bedding and nightclothes (pajamas) after treatment may help to prevent this. Some doctors may also recommend other measures to help keep your infection from returning. If you have any questions about this, check with your doctor.

pyrvinium Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Skin rash

Rare

Diarrhea

increased sensitivity of skin to sunlight

nausea and vomiting

stomach cramps

pyrvinium is a dye and will color your stools red. This color is not harmful and will disappear in a few days. Pyrvinium may also stain clothing red. If vomiting occurs, the vomit will be red in color.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Zolmitriptan

Class: Selective Serotonin Agonists
VA Class: CN105
Chemical Name: (S)-4-[[3-[2-(dimethylamino)ethyl]indol-5-yl]methyl]-2-oxazolidinone
Molecular Formula: C₁₆H₂₁N₃O₂
CAS Number: 139264-17-8
Brands: Zomig

Introduction

Selective serotonin (5-hydroxytryptamine; 5-HT) type 1B and 1D receptor agonist (“triptan”).¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹⁴ ¹⁵ ²¹ ²² ²³ ²⁴ ²⁷

Uses for Zolmitriptan

Vascular Headaches

Acute treatment of migraine attacks with or without aura.¹ ²⁷

Not recommended for management of hemiplegic or basilar migraine or for prophylaxis of migraine.¹ ²⁷

Safety and efficacy not established for management of cluster headaches.¹ ²⁷

Zolmitriptan Dosage and Administration

Administration

Administer orally or intranasally.¹ ²⁷ ²⁸

Oral Administration

Administer orally as conventional or orally disintegrating tablets without regard to meals.¹

To achieve a dose <2.5 mg, manually break the scored 2.5-mg conventional tablet in half.¹ Do not break orally disintegrating tablets.¹

Just prior to administration of orally disintegrating tablet, remove tablet from blister package; peel open blister package, place tablet on tongue to dissolve, and swallow with saliva.¹

Administration of orally disintegrating tablet with liquid is not necessary.¹

Intranasal Administration

Administer intranasally as a single spray into 1 nostril.²⁸

Do not spray contents into eyes.²⁸

To administer, blow nose gently and remove protective cap just before use.²⁸ Hold nasal spray device gently and do not press plunger until tip is placed into nostril.²⁸ Block one nostril by pressing firmly on side of nose and put tip into other nostril as far as feels comfortable.²⁸ Tilt head slightly back and breathe gently through nose while pressing plunger firmly with thumb; a click may be heard.²⁸ Keep head tilted slightly back and remove tip of device from nose; breathe gently through mouth for 5–10 seconds.²⁸ Liquid may be felt in nose or back of throat.²⁸ Consult manufacturer’s patient information for complete directions.²⁸

Single-use spray pump; discard after use.²⁷

Dosage

Due to similarity in systemic exposure, dosage adjustments with oral and intranasal formulations should be similar; doses <5 mg can be achieved only through use of oral formulations.²⁷

Adults

Vascular Headaches

Migraine

Oral

Initially, ≤2.5 mg.¹ In clinical studies, single oral doses of 1 (not commercially available in US), 2.5, or 5 mg were effective, but the 2.5- and 5-mg doses were effective in a greater proportion of patients.¹ The 5-mg dose appears to offer little additional benefit and is associated with increased risk of adverse effects.¹

If headache recurs, dose may be repeated after ≥2 hours.¹

Following failure to respond to first dose, reconsider diagnosis of migraine prior to administration of a second dose.¹

Intranasal

5 mg (1 spray) as a single dose; individualize selection of dosage and administration route.²⁷

If headache recurs, dose may be repeated after 2 hours.²⁷

Following failure to respond to first dose, reconsider diagnosis of migraine prior to administration of a second dose.²⁷

Prescribing Limits

Adults

Vascular Headaches

Migraine

Oral

Maximum 10 mg in any 24-hour period.¹

Safety of treating an average of >3 headaches per 30-day period has not been established.¹

Intranasal

Maximum 10 mg in any 24-hour period.²⁷

Safety of treating an average of >4 headaches per 30-day period has not been established.²⁷

Special Populations

Hepatic Impairment

Generally use <2.5 mg as a single oral dose in patients with moderate to severe hepatic impairment; concurrent BP monitoring recommended.¹

Recommended doses can be achieved only with oral formulations; use of intranasal formulation not recommended.²⁷

Cautions for Zolmitriptan

Contraindications

Known or suspected ischemic heart disease (e.g., angina pectoris, history of MI, documented silent ischemia).¹ ²⁷

Coronary artery vasospasm (e.g., Prinzmetal variant angina).¹ ²⁷

Other serious underlying cardiovascular disease (e.g., uncontrolled hypertension).¹ ²⁷

Cerebrovascular syndromes (e.g., stroke syndromes, TIAs).²⁷

Hemiplegic or basilar migraine.¹ ²⁷

Treatment within previous 24 hours with another 5-HT₁ receptor agonist or an ergot alkaloid.¹ ²⁷ (See Specific Drugs under Interactions.)

Concurrent or recent (within 2 weeks) treatment with an MAO-A inhibitor.¹ ²⁷ (See Specific Drugs under Interactions.)

Known sensitivity to zolmitriptan or any ingredient in the formulation.¹ ²⁷

Warnings/Precautions

Warnings

Use only in patients in whom a clear diagnosis of migraine has been established.¹ ²⁷

Cardiac Effects

Risk of coronary vasospasm, myocardial ischemia and/or infarction, life-threatening cardiac rhythm disturbances, and death with use of 5-HT₁ receptor agonists.¹ ²⁷

Use not recommended in patients with symptomatic Wolff-Parkinson-White syndrome or cardiac arrhythmias associated with other accessory pathway conduction disorders.¹ ²⁷

Use not recommended in patients with known or suspected ischemic or vasospastic heart disease or in patients in whom unrecognized CAD is likely (e.g., postmenopausal women; men >40 years of age; patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, diabetes, or family history of CAD) unless there is satisfactory evidence from prior cardiovascular evaluation that patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.¹ ²⁷

Administer initial dose to patients with risk factors for CAD who have completed satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician's office, possibly followed by ECG) unless patient previously received the drug.¹ ²⁷

Periodic cardiovascular evaluation recommended in patients with risk factors for CAD if receiving intermittent long-term therapy.¹ ²⁷

Patients with symptoms suggestive of angina after receiving zolmitriptan should be evaluated for the presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses.¹ ²⁷

Cerebrovascular Events

Possible cerebral or subarachnoid hemorrhage, stroke, and other cerebrovascular events, sometimes fatal, with use of 5-HT₁ receptor agonists.¹ ²⁷

Risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA) may be increased in patients with migraine.¹ ²⁷

Other Cardiovascular or Vasospastic Effects

Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea reported with use of 5-HT₁ receptor agonists.¹ ²⁷ Further evaluation recommended if signs or symptoms of decreased arterial flow (e.g., ischemic bowel syndrome, Raynaud's syndrome) occur following administration.¹ ²⁷

Substantial increases in BP, including hypertensive crises, reported rarely with 5-HT₁ receptor agonists in patients with or without history of hypertension.¹ ²⁷

Increases in mean pulmonary artery pressure observed following administration of a 5-HT₁ receptor agonist to patients with suspected CAD who were undergoing cardiac catheterization.¹ ²⁷

Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with 5-HT₁ receptor agonists (“triptans”) and SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs).²⁷ ²⁹ Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).²⁷ ²⁹

Local Effects

Possible local irritation or soreness after intranasal administration.²⁷ Adverse effects perceived in nasopharynx, occasionally severe, usually resolve within 1 hour.²⁷

No clinically important nasopharyngeal changes observed by examination following repeated use for up to 1 year’s duration.²⁷

General Precautions

Ocular Effects

Possible accumulation of zolmitriptan and/or its metabolites in melanin-rich tissues (e.g., eye) over time, resulting in potential toxicity in these tissues with extended use.¹ ²⁷

Phenylketonuria

Each 2.5- or 5-mg Zomig-ZMT orally disintegrating tablet contains aspartame, which is metabolized in GI tract to provide 2.81 or 5.62 mg of phenylalanine, respectively.¹ Conventional tablets do not contain aspartame.¹

Specific Populations

Pregnancy

Category C.¹ ²⁷

Lactation

Distributed into milk in rats; not known whether distributed into human milk.¹ ²⁷ Caution advised if zolmitriptan is used.¹ ²⁷

Pediatric Use

Safety and efficacy not established in children <18 years of age; use not recommended.¹ ²⁷

Geriatric Use

Pharmacokinetic profile similar to that in younger adults.¹ ²⁷ However, patients >65 years of age were excluded from clinical studies; safety and efficacy not established.¹ ²⁷

Hepatic Impairment

Substantial elevation of BP observed in some patients with moderate-to-severe hepatic impairment following 10-mg oral dose.¹ ²⁷ Use with caution in patients with hepatic impairment;¹ ²⁷ BP monitoring and dosage adjustment recommended.¹ ²⁷

Common Adverse Effects

Dizziness,¹ ²⁷ paresthesia,¹ ²⁷ hyperesthesia,¹ ²⁷ neck/throat/jaw/chest symptoms (e.g., pain, tightness, pressure, heaviness),¹ ²⁷ nausea,¹ ²⁷ somnolence,¹ ²⁷ warm or cold sensation,¹ asthenia,¹ ²⁷ dry mouth,¹ ²⁷ dyspepsia¹ ; with intranasal therapy, also nasal cavity disorder/discomfort,²⁷ unusual taste.²⁷

Interactions for Zolmitriptan

Appears to be metabolized by CYP1A2; active N-desmethyl metabolite appears to be further metabolized by MAO-A.²² ²³ ²⁴ ²⁶

Specific Drugs

Drug	Interaction	Comments
Acetaminophen	Increased time to peak plasma acetaminophen concentrations¹ ²⁷
Antidepressants, SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) and SNRIs (e.g., duloxetine, venlafaxine)	Potentially life-threatening serotonin syndrome²⁷ ²⁹ Zolmitriptan pharmacokinetics or effect on BP not altered by fluoxetine pretreatment¹ ²⁷ ³⁰	Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated²⁷ ²⁹
Cimetidine	Increased half-life and systemic exposure to zolmitriptan and its active metabolite¹ ²⁷
Ergot alkaloids (e.g., ergotamine, dihydroergotamine, methysergide)	Additive vasospastic effects¹ ²⁷	Use within 24 hours contraindicated¹ ²⁷
5-HT₁ receptor agonists	Additive vasospastic effects¹ ²⁷	Use within 24 hours contraindicated¹ ²⁷
MAO inhibitors	Increased plasma concentrations of zolmitriptan and its active metabolite with concurrent use of MAO-A inhibitors; ¹ ²⁷ selegiline (selective MAO-B inhibitor) did not affect pharmacokinetics of zolmitriptan or its active metabolite²⁷	Use of oral or intranasal zolmitriptan within 2 weeks of MAO-A inhibitor contraindicated¹ ²⁷
Metoclopramide	Metoclopramide (single 10-mg dose) did not affect pharmacokinetics of zolmitriptan or its metabolites¹ ²⁷
Oral contraceptives	Increased plasma zolmitriptan concentrations¹ ²⁷
Propranolol	Increased plasma zolmitriptan concentrations; peak zolmitriptan concentration may be delayed¹ ²⁷
Xylometazoline	Topical application of xylometazoline to nasal mucosa 30 minutes prior to intranasal zolmitriptan did not affect zolmitriptan pharmacokinetics²⁷

Zolmitriptan Pharmacokinetics

Absorption

Bioavailability

Well absorbed after oral administration, with peak plasma concentrations attained within 1.5 hours (conventional tablets) or 3 hours (orally disintegrating tablets).¹ Rapidly absorbed via the nasopharynx after intranasal administration, with peak plasma concentrations attained within 3 hours.²⁷

Mean absolute bioavailability after oral administration is approximately 40%;¹ mean bioavailability of nasal solution is 102% compared with oral tablet.²⁷

Mean plasma concentrations after oral administration are increased by up to 1.5-fold in females compared with males.¹ ²⁷

Food

Food does not substantially affect bioavailability.¹ ²⁷

Distribution

Plasma Protein Binding

25%.¹ ²⁷

Elimination

Metabolism

Undergoes hepatic metabolism to form 3 principal metabolites, including N-desmethyl zolmitriptan (5-HT_1B/1D potency is 2–6 times that of zolmitriptan).¹ ²² ²³ ²⁴ ²⁷ Formation of N-desmethyl zolmitriptan may depend on CYP1A2; MAO-A appears to mediate metabolism of N-desmethyl zolmitriptan.²² ²³ ²⁴ ²⁶

Elimination Route

Excreted in urine (65%) and feces (30%) as unchanged drug and metabolites;¹ ²⁴ dose recovered in urine as unchanged drug (8%) and indole acetic acid (31%), N-oxide (7%), and N-desmethyl (4%) metabolites.¹

Half-life

Approximately 3 hours for zolmitriptan and active N-desmethyl metabolite after oral or intranasal administration.¹ ¹³ ²³ ²⁴ ²⁷

Special Populations

In patients with severe hepatic impairment, peak plasma concentrations, time to achieve peak plasma concentrations, and AUC are 1.5-, 2-, and 3-fold higher, respectively, than in healthy individuals after oral administration.¹ ²⁷ Pharmacokinetics of nasal spray not evaluated in patients with hepatic impairment.²⁷

In patients with severe renal impairment (Cl_cr 5–25 mL/minute), clearance is reduced by 25% after oral administration; no substantial change in clearance in patients with moderate renal impairment (Cl_cr 26–50 mL/minute).¹ Pharmacokinetics of nasal spray not evaluated in patients with renal impairment.²⁷

Stability

Storage

Oral

Conventional and Orally Disintegrating Tablets

20–25°C; protect from light and moisture.¹

Intranasal

Solution

20–25°C.²⁷

ActionsActions

Binds with high affinity to 5-HT_1B and 5-HT_1D receptors.¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹⁴ ¹⁵ ²¹ ²² ²³ ²⁴ ²⁷

Structurally and pharmacologically related to other selective 5-HT_1B/1D receptor agonists (e.g., almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan).²¹ ²²

Precise mechanism of action not established; may ameliorate migraine through selective constriction of certain intracranial blood vessels, inhibition of neuropeptide release, and reduced transmission in trigeminal pain pathway.¹ ²¹ ²² ²³ ²⁷

Advice to Patients

Importance of immediately informing clinician of occurrence of tightness, pain, pressure, or heaviness in chest, throat, jaw, or neck; sudden or severe abdominal pain; shortness of breath or wheezing; heart throbbing; facial swelling (e.g., eyelids, face, lips); tongue, mouth or throat swelling; rash or hives and of not taking zolmitriptan again until evaluated by a clinician.¹ ²⁷ Importance of informing clinician of any other symptoms not understood by patient.¹ ²⁷

Importance of adhering to prescribed directions for use.¹ ²⁷ ²⁸ Importance of patient reading manufacturer's patient information before initial use and each time prescription is refilled.¹ ²⁸

For patients taking zolmitriptan orally disintegrating tablets, importance of not removing tablet from blister package until just before administering dose;¹ importance of peeling blister open and placing tablet on tongue to dissolve and be swallowed with saliva.¹

Importance of informing patients with phenylketonuria that orally disintegrating tablets contain aspartame.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, dietary supplements, and herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease).¹ ²⁷

Importance of informing patients of risk of serotonin syndrome with concurrent use of zolmitriptan and an SSRI or SNRI.²⁷ ²⁹ Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.²⁷ ²⁹

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ ²⁷

Importance of informing patients of other important precautionary information.¹ ²⁷ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Zolmitriptan
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Nasal	Solution	5 mg/0.1 mL	Zomig Nasal Spray	AstraZeneca
Oral	Tablets, film-coated	2.5 mg	Zomig	AstraZeneca
		5 mg	Zomig	AstraZeneca
	Tablets, orally disintegrating	2.5 mg	Zomig-ZMT (with aspartame)	AstraZeneca
		5 mg	Zomig-ZMT (with aspartame)	AstraZeneca

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Zomig 2.5MG Tablets (ASTRAZENECA): 6/$156 or 18/$441.97

Zomig 5MG Solution (ASTRAZENECA): 6/$216 or 18/$615.99

Zomig 5MG Tablets (ASTRAZENECA): 3/$95.99 or 9/$259.96

Zomig ZMT 2.5MG Dispersible Tablets (ASTRAZENECA): 6/$155.99 or 18/$452.99

Zomig ZMT 5MG Dispersible Tablets (ASTRAZENECA): 3/$85.99 or 9/$230.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

References

1. AstraZeneca Pharmaceuticals LP. Zomig (zolmitriptan) tablets and Zomig-ZMT(zolmitriptan) orally disintegrating tablets prescribing information. Wilmington, DE; 2005 May.

2. Visser WH, Klein KB, Cox RC et al. 311C90, a new central and peripherally acting 5-HT1D receptor agonist in the acute oral treatment of migraine: a double-blind, placebo-controlled, dose-range finding study. Neurology. 1996; 46:522-6.

3. Dahlof C, Diener HC, Goadsby PJ et al. Zolmitriptan, a 5-HT1B/1D receptor agonist for the acute oral treatment of migraine: a multicentre, dose-range fnding study. Eur J Neurol 1998; 5:535-43. [PubMed 10210888]

4. Rapoport AM, Ramadan NM, Adelman JU et al. Optimizing the dose of zolmitriptan (Zomig, 311C90) for the acute treatment of migraine. A multicenter, double-blind, placebo-controlled, dose range-finding study. Neurology. 1997; 49:1210-8. [IDIS 397204] [PubMed 9371896]

5. Solomon GD, Cady RK, Klapper JA et al. Clinical efficacy and tolerability of 2.5 mg zolmitriptan for the acute treatment of migraine. Neurology. 1997; 49:1219-25. [IDIS 397205] [PubMed 9371897]

6. Dowson AJ, MacGregor EA, Purdy RA et al. Zolmitriptan orally disintegrating tablet is effective in the acute treatment of migraine. Cephalalgia. 2002; 22:101-6. [PubMed 11972576]

7. The International 311C90 Long-term Study Group. The long-term tolerability and efficacy of oral zolmitriptan (Zomig, 311C90) in the acute treatment of migraine. An international study. Headache. 1998; 38:173-83. [PubMed 9563207]

8. Tepper SJ, Donnan GA, Dowson AJ et al. A long-term study to maximize migraine relief with zolmitriptan. Curr Med Res Opin. 1999; 15:254-71. [PubMed 10640258]

9. Tuchman M, Edvinsson L, Geraud G et al. Zolmitriptan provides consistent migraine relief when used in the long-term. Curr Med Res Opin. 1999; 15:272-81. [PubMed 10640259]

10. Gallagher RM, Dennish G, Spierings ELH et al. A comparative trial of zolmitriptan and sumatriptan for the acute oral treatment of migraine. Headache. 2000; 40:119-28. [PubMed 10759911]

11. Gruffyd-Jones K, Kies B, Middleton A et al. Zolmitriptan versus sumatriptan for the acute oral treatment of migraine: a randomized, double-blind, international study. Eur J Neurol. 2001; 8:237-45.

12. Oldman AD, Smith LA, McQuay HJ et al. Pharmacological treatment for acute migraine: quantitative systematic review. Pain. 2002; 97:247-57.

13. Ferrari MD, Goadsby PJ, Roon KI et al. Triptans (serotonin, 5-HT1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trials. Cephalalgia. 2002; 22:633-58. [PubMed 12383060]

14. Matchar DB, Young WB, Rosenberg JH et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management of acute attacks. From American Academy of Neurology web site ().

15. Silberstein SD, for the US Headache Consortium. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the quality standards subcommittee of the American Academy of Neurology. Neurology. 2000; 55:754-63. [IDIS 453389] [PubMed 10993991]

16. American Medical Association Council on Scientific Affairs. Aspartame: review of safety issues. JAMA. 1985; 254:400-2. [IDIS 202002] [PubMed 2861297]

17. Gossel TA. A review of aspartame: characteristics, safety and uses. US Pharm. 1984; 9:26,28-30.

18. Food and Drug Administration. Aspartame as an inactive ingredient in human drug products; labeling requirements. Proposed rule. [21 CFR Part 201] Fed Regist. 1983; 48:54993-5.

19. Food and Drug Administration. Food additives permitted for direct addition to food for human consumption; aspartame. Final rule. [21 CFR Part 172] Fed Regist. 1983; 48:31376-82.

20. Anon. Aspartame and other sweeteners. Med Lett Drugs Ther. 1982; 24:1-2.

21. Tfelt-Hansen P, De Vries P, Saxena PR. Triptans in migraine. A comparative review of pharmacology, pharmacokinetics, and efficacy. Drugs. 2000; 60:1259-87.

22. Deleu D, Hanssens Y. Current and emerging second-generation triptans in acute migraine therapy: a comparative review. J Clin Pharmacol. 2000; 40:687-700. [IDIS 449430] [PubMed 10883409]

23. Dowson AJ, Charlesworth B. Review of zolmitriptan and its clinical applications in migraine. Expert Opin Pharmacother. 2002; 3:993-1005. [PubMed 12083998]

24. Spencer CM, Gunasekara NS, Hills C. Zolmitriptan. A review of its use in migraine. Drugs. 1999; 58:347-74. [PubMed 10473025]

25. GlaxoSmithKline. Amerge (naratriptan hydrochloride) tablets prescribing information. Research Triangle Park, NC; 2002 Oct.

26. AstraZeneca, Wilmington, DE: Personal communication.

27. AstraZeneca. Zomig (zolmitriptan) nasal spray prescribing information. Wilmington, DE; 2006 July.

28. AstraZeneca. Zomig (zolmitriptan) nasal spray patient summary of information. Wilmington, DE; 2005 Jun.

29. Food and Drug Administration. Public health advisory: combined use of 5-hydroxytryptamine receptor agonists (triptans), selective serotonin reuptake inhibitors (SSRIs) or selective serotonin/norepinephirne reuptake inhibitors (SNRIs) may result in life-threatening serotonin syndrome. Rockville, MD; 2006 Jul 19. From the FDA website: (, , and ).

30. Smith DA, Cleary EW, Watkins S et al. Zolmitriptan (311C90) does not interact with fluoxetine in healthy volunteers. Int J Clin Pharmacol Ther. 1998; 36:301-5. [PubMed 9660035]

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Introduction