Ausfam - Precautions | Dosage | Effects
Ausfam contains the active substance known as famotidine and belongs to the class of medicines called H2 antihistamines. It works by inhibiting nocturnal, basal and food-stimulated gastric acid secretion. The onset of effect following oral administration is within 1 hour, while the maximum effect is achieved in within 3 hours. The effect of the drug lasts 10-12 hours.
It is used as a short-term treatment of the following conditions:
- Gastric ulcer
- Duodenal ulcer
- Gastroesophageal reflux disease (GERD)
- Zollinger-Ellison syndrome
- Multiple endocrine adenoma
It is also used to prevent relapse of symptoms and ulcerations caused by gastroesophageal reflux disease.
Ausfam should not be used in patients who have or have had hypersensitivity / allergic reactions to any of the H2 antihistamines (e.g. ranitidine and famotidine).
65-70% of the drug is excreted via the kidneys, therefore it should be used cautiously in patients with moderate (eGFR less than 50 ml / min) or severe renal impairment (eGFR less than 10 ml / min), since such patients have extended elimination half-life, which means that the concentration of the drug in the blood is also increased. Increased concentration of Ausfam in the blood can lead to central nervous system side effects (headache, dizziness, convulsions, somnolence, and paresthesia).
Arrhythmias due to QT prolongation have been very rarely reported when this medicine was administered in patients with impaired renal function.
If used as a long-term therapy, then periodic monitoring of complete blood count and liver function is recommended.
Since it increases the pH in the stomach, Ausfam can reduce the absorption of certain drugs and reduce their efficacy, so the simultaneous administration with the following drugs is contraindicated:
- Atazanavir and atazanavir / cobicistat - drugs used for the treatment of HIV infection.
- Dasatinib - drug used to treat chronic myeloid leukemia.
- Pazopanib - drug used to treat renal cell carcinoma and soft tissue sarcoma.
It should not be used in patients who have active gastrointestinal bleeding (symptoms include: presence of streaks of blood in the vomit and presence of blood in the stool) as these symptoms may indicate malignant changes. For this reason, upper endoscopy should be carried out prior to initiation of therapy to exclude malignant changes.
Ausfam, Pregnancy and Breastfeeding
Ausfam belongs to pregnancy category B. Studies that have been performed in rats and rabbits have revealed no toxic effects on the fetus, but it is not possible to exclude the possibility of occurrence of adverse effects in pregnant women.
It is excreted into human milk and so it recommended to avoid breastfeeding or taking this drug in lactating women.
Since Ausfam has shown an exceptional effect on the inhibition of nocturnal secretion (up to 90%) if taken at night, it is recommended to take Ausfam tablets at bedtime.
The usual dose for the treatment of gastric and duodenal ulcers is 40 mg once daily, at bedtime. The therapy usually lasts 4-8 weeks.
The usual dose for the treatment of gastroesophageal reflux disease is 20 mg once daily, at bedtime. The therapy lasts for up to 12 weeks.
The usual dose for the treatment of Zollinger-Ellison syndrome is 20 mg every 6 hours (four times a day). High doses (160 mg every 6 hours) can be used in patients who have a severe form of the Zollinger-Ellison syndrome. Cases of patients taking 800 mg/day of this drug for one year without any adverse effects have been reported.
Ausfam may reduce the absorption of antifungal drugs (e.g. itraconazole and ketoconazole) and therefore can reduce their efficacy. If you are taking these medicines, you should wait at least three hours before taking Ausfam tablets.
If you are taking sucralfate (a medicine that is used in the treatment of ulcers), you also need to wait at least three hours before taking Ausfam tablets.
Probenecid (a medicine used to treat gout) can increase the plasma levels of Ausfam and thus increase the risk of side effects.
Ausfam may cause the following side effects:
- Dry mouth
- Stomach upset
- Low libido
- Depressive symptoms
- Cholestatic jaundice and impaired liver function
- Angioneurotic edema
- Stevens-Johnson syndrome
- Hair loss
- AV block
- Prolonged QT interval
- Muscle cramps
- Taste disorders