ADALAT GITS 60MG TABLET
Adalat GITS prolonged-release tablet also contains the following inactive ingredients: Hypromellose, polyethylene oxide, magnesium stearate, sodium chloride, red iron oxide (E172/CI 77491), cellulose acetate, polyethylene glycol 3350, hydroxypropyl cellulose, propylene glycol, titanium dioxide (E171/CI 77891).
Indications / Uses :
Treatment of coronary heart disease: Chronic stable angina pectoris (angina of effort).
Treatment of hypertension.
May be taken with or without food: Avoid grapefruit juice. Swallow whole, do not chew/crush.
Known hypersensitivity to nifedipine. Cardiovascular shock. Patients with Kock pouch (ileostomy after proctocolectomy). Pregnancy before week 20 and during breastfeeding.
Nifedipine must not be used in combination with rifampicin because no efficient plasma levels of nifedipine may be obtained due to enzyme induction.
In vitro Fertilization: In single cases of in vitro fertilization, calcium antagonists like nifedipine have been associated with reversible biochemical changes in the spermatozoa’s head section that may result in impaired sperm function. In those men who are repeatedly unsuccessful in fathering a child by in vitro fertilization, and where no other explanation can be found, calcium antagonists like nifedipine should be considered as possible causes.
Use in pregnancy: Nifedipine is contraindicated in pregnancy before week 20. There are no adequate and well controlled studies in pregnant women. In animal studies nifedipine has been shown to produce embryotoxicity, fetotoxicity and teratogenicity.
Use in lactation: Nifedipine passes into the breast milk. As there is no experience of possible effects on infants, breastfeeding should first be stopped if nifedipine treatment becomes necessary during breastfeeding period.
Special Precautions :
Care must be exercised in patients with very low blood pressure (severe hypotension with systolic pressure <90 mm Hg), in cases of manifest heart failure and in the case of severe aortic stenosis.
Careful monitoring of blood pressure must be exercised, also when administering nifedipine with IV magnesium sulfate, owing to the possibility of an excessive fall in blood pressure which could harm both mother and fetus.
As with other nondeformable material, care should be used when administering Adalat GITS 20/30/60 in patients with preexisting severe gastrointestinal narrowing because obstructive symptoms may occur.
Bezoars can occur in very rare cases and may require surgical intervention.
In single cases obstructive symptoms have been described without known history of gastrointestinal disorders.
When doing barium contrast x-ray, Adalat GITS may cause false positive effects (eg, filling defects interpreted as polyp).
In patients with impaired liver function, careful monitoring and, in severe cases, a dose reduction may be necessary.
Effects on the Ability to Drive or Operate Machinery: Reactions to the drug, which vary in intensity from individual to individual, can impair the ability to drive or to operate machinery. This applies particularly at the start of treatment, on changing the medication and in combination with alcohol.
Use In Pregnancy & Lactation
Use in Pregnancy: Nifedipine is contraindicated in pregnancy before week 20. There are no adequate and well controlled studies in pregnant women. In animal studies nifedipine has been shown to produce embryotoxicity, fetotoxicity and teratogenicity.
Use in Lactation: Nifedipine passes into the breast milk. As there is no experience of possible effects on infants, breastfeeding should first be stopped if nifedipine treatment becomes necessary during breastfeeding period.
Caution for Usage
In Adalat GITS, the medication is contained within a nonabsorbable shell that slowly releases the drug for the body to absorb. When this process is completed, the empty tablet is eliminated from the body and may be noticed in the stool.
The light-sensitive active substance contained in Adalat GITS is protected from light inside and outside its packaging. The tablets must be protected from humidity and must therefore only be removed from the foil immediately before use.