Indications
Famotac Tablet is used for:
Heartburn, Peptic ulcer, Dyspepsia, Urticaria, Zollinger-Ellison syndrome, Gastroesophageal reflux disease (GERD)
Adult Dose
Oral
Benign gastric and duodenal ulceration
Adult: 40 mg daily at bedtime for 4-8 wk or 20 mg bid. Maintenance: 20 mg at bedtime to prevent recurrence of duodenal ulceration.
Gastro-oesophageal reflux disease
Adult: 20 mg bid for 6-12 wk or up to 40 mg bid if there is oesophageal ulceration. Maintenance: 20 mg bid to prevent recurrence.
Zollinger-Ellison syndrome
Adult: Initially, 20 mg 6 hrly, up to 800 mg/day if necessary.
Non-ulcer dyspepsia ; Heartburn
Adult: 10-20 mg once or bid.
Child Dose
Peptic Ulcer
1-16 years: 0.5 mg/kg PO at bedtime; not to exceed 40 mg/day
Gastroesophageal Reflux Disease
<3 months: 0.5 mg/kg PO once daily for up to 8 weeks
3-12 months: 0.5 mg/kg PO q12hr for up to 8 weeks
1-16 years: 1 mg/kg/day PO divided q12hr; individual dose not to exceed 40 mg
Heartburn
<12 years: Not established
>12 years: 10-20 mg q12 hr; may take 15-60 min before eating foods that could cause heartburn
Renal Dose
Renal impairment:
CrCl (ml/min) Dosage Recommendation
<50 Reduce the dose by half or increase dosing interval to 36-48 hr.
Administration
May be taken with or without food.
Reconstitution: For IV inj: Famotidine 20 mg is diluted to a total of 5 or 10 mL w/ NaCl 0.9% inj or dextrose 5% or 10% inj, lactated Ringer's, water for inj soln to provide a soln containing approx 4 or 2 mg/mL, respectively.
For intermittent IV infusion: Famotidine 20 mg is added to dextrose 5% inj 100 mL or NaCl 0.9% inj, lactated Ringer's soln, water for inj soln to provide a soln containing approximately 0.2 mg/mL.
IV Administration
Infuse at rate no faster than 10 mg/min
Contra Indications
Hypersensitivity.
Precautions
Impaired renal function. Long term treatment should be avoided.
Lactation: Drug enters breast milk; use not recommended
Pregnancy-Lactation
Pregnancy
Available data in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
Animal data
Animal reproduction studies have shown no adverse development effects at doses up to approximately 243 times, the recommended human dose of 80 mg per day for treatment of erosive esophagitis
Lactation
There are limited data available on presence in human breast milk; there were no effects on breastfed infant; there are no data on famotidine effects on milk production; drug reported present in milk of lactating rats; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for famotidine and any potential adverse effects on breastfed child or from underlying maternal condition
Interactions
Antacids slightly decrease the bioavailability of famotidine. May reduce serum concentration of ketoconazole and itraconazole.
Side Effects
Side effects of Famotidine :
1-10%
Headache (4.7%), Diarrhea (1.7%), Dizziness (1.3%), Constipation (1.2%)
Frequency Not Defined
Body as a whole: Fever, asthenia, fatigue
Cardiovascular: Arrhythmia, AV block, palpitation; prolonged QT interval in patients with impaired renal function, has been reported very rarely
Gastrointestinal: Cholestatic jaundice, hepatitis, liver enzyme abnormalities, vomiting, nausea, abdominal discomfort, anorexia, dry mouth
Hematologic: Rare cases of agranulocytosis, pancytopenia, leukopenia, thrombocytopenia
Hypersensitivity: Anaphylaxis, angioedema, orbital or facial edema, urticaria, rash, conjunctival injection
Musculoskeletal: Rhabdomyolysis, musculoskeletal pain including muscle cramps, arthralgia
Nervous system/psychiatric: Grand mal seizure; psychic disturbances, which were reversible in cases for which follow-up was obtained, including hallucinations, confusion, agitation, depression, anxiety, decreased libido; paresthesia; insomnia; somnolence; convulsions, in patients with impaired renal function, have been reported very rarely
Respiratory: Bronchospasm, interstitial pneumonia
Skin: Toxic epidermal necrolysis/Stevens-Johnson syndrome (very rare), alopecia, acne, pruritus, dry skin, flushing
Special senses: Tinnitus, taste disorder
Rare cases of impotence and rare cases of gynecomastia
Mode of Action
Famotidine competitively blocks histamine at H2-receptors thus reducing basal, nocturnal and stimulated gastric acid secretion. Pepsin secretion is reduced resulting in decreased peptic activity.
Note
Famotac 20 mg, 40 mg Tablet generic name is Famotidine. Famotac 20 mg, 40 mg Tablet is manufactured by Ambee Pharmaceuticals Ltd.Famotac is availble in all over Bangladesh.
Mes BD drug index information on Famotac Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.