DDR 30 mg 10's Strip Capsule

Summary:

Indications of DDR 30 mg

Healing of Erosive Esophagitis: DDR 30 mg is indicated for the healing of all grades of erosive esophagitis (EE) for up to 8 weeks.Maintenance of Healed Erosive Esophagitis: DDR 30 mg is indicated to maintain healing of EE and relief of heartburn ... Read moreHealing of Erosive Esophagitis: DDR 30 mg is indicated for the healing of all grades of erosive esophagitis (EE) for up to 8 weeks.Maintenance of Healed Erosive Esophagitis: DDR 30 mg is indicated to maintain healing of EE and relief of heartburn for up to 6 months.Symptomatic Non-Erosive Gastroesophageal Reflux Disease: DDR 30 mg is indicated for the treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD) for 4 weeks.

Theropeutic Class

Proton Pump Inhibitor

Pharmacology

DDR 30 mg delayed-release capsule is a Proton Pump Inhibitor (PPI), that inhibits gastric acid secretion. It is the R-enantiomer of lansoprazole (A racemic mixture of the R- and S-enantiomers). This is supplied as a Dual Delayed Release (DDR) formulation in a capsule for oral administration. DDR 30 mg capsule contains a mixture of two types of enteric coated granules with different pH-dependent dissolution profiles.DDR 30 mg is a PPI that suppresses gastric acid secretion by specific inhibition of the (H /K )-ATPase in the gastric parietal cell. By acting specifically on the proton pump, DDR 30 mg blocks the final step of acid production.

Dosage of DDR 30 mg

DDR 30 mg dosing recommendations- Maintenance of Healed erosive esophagitis and relief of heartburn: 30 mg Once daily Symptomatic Non-Erosive GERD: 30 mg Once daily for 4 weeks Healing of erosive esophagitis: 60 mg Once daily for up to 8 weeks

Administration of DDR 30 mg

DDR 30 mg can be taken without regard to food. It should be swallowed whole. Alternatively, DDR 30 mg capsules can be administered as follows: Open capsule Sprinkle intact granules on one tablespoon Swallow immediately. Granules should not be chewed.If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose, only the prescribed dose should be taken at the appointed time. A double dose should not be taken.

Interaction of DDR 30 mg

With medicine: Atazanavir, Warfarin, Tacrolimus, Clopidogrel and Methotrexate. With food and others: No data available.

Contraindications

DDR 30 mg is contraindicated in patients with known hypersensitivity to any component of the formulation.

Side Effects of DDR 30 mg

Common side effects: Diarrhea, abdominal pain, nausea, vomiting and flatulence.

Pregnancy and Lactation

There are no adequate or well-controlled studies in pregnant women with DDR 30 mg. Exposure in clinical trials was very limited. DDR 30 mg should not be administered to pregnant women unless the expected benefits outweigh the potential risks. It is not known whether DDR 30 mg is excreted in human milk. However, DDR 30 mg and its metabolites are excreted in the milk of rats. As many drugs are excreted in human milk, DDR 30 mg should not be given to nursing mothers unless its use is considered

Precautions and Warnings

Gastric Malignancy, Clostridium difficile Associated Diarrhea, Bone fracture, Hypomagnesemia, and concomitant use of DDR 30 mg with Methotrexate.

Overdose Effects of DDR 30 mg

There have been no reports of a significant overdose of DDR 30 mg. Multiple doses of DDR 30 mg 120 mg and a single dose of DDR 30 mg 300 mg did not result in death or other severe adverse events.

Storage Conditions

Store below 30°C temperature and in a dry place, protected from light. Keep all medicines out of reach of children.

Use In Special Populations

Geriatrics: No dosage adjustment is necessary for elderly patients.Pediatrics: Safety and effectiveness of DDR 30 mg in patients below 12 years age have not been established yet.Renal Impairment: No dosage adjustment is necessary for patients with renal impairment.Hepatic Impairment: No adjustment of DDR 30 mg is necessary for patients with mild hepatic impairment. A maximum daily dose of 30 mg for patients with moderate hepatic impairment may be considered.

Drug Classes

Proton Pump Inhibitor

Mode Of Action

DDR 30 mg delayed-release capsule is a Proton Pump Inhibitor (PPI) which suppresses gastric acid secretion by specific inhibition of the (H /K )-ATPase in the gastric parietal cell. By acting specifically on the proton pump, DDR 30 mg blocks the final step of acid production. It is the R-enantiomer of lansoprazole (A racemic mixture of the R- and S-enantiomers). DDR 30 mg is supplied as a Dual Delayed Release (DDR) formulation in a capsule for oral administration. This capsule contains a mixture of two types of enteric coated granules with different pH-dependent dissolution profiles. The dual delayed release formulation in DDR 30 mg, plasma concentration-time profile with two distinct peaks; the first peak occurs 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours. After oral administration, mean Cmax and AUC value of DDR 30 mg increased approximately dose proportionally. DDR 30 mg is extensively metabolized in the liver and excreated by urine.

Pregnancy

Pregnancy Category B. There is no adequate and well-controlled studies with DDR 30 mg in pregnant women. There is no adequate and well-controlled studies with DDR 30 mg in Lactating mother.

Pediatric Uses

Use in children and adolescents: Safety and effectiveness of DDR 30 mg in patients below 12 years age have not been established.Geriatric use: No dose adjustment is necessary for elderly patients.Renal impairment: No dose adjustment of DDR 30 mg is necessary for patients with renalimpairment.Hepatic impairment: No dose adjustment for DDR 30 mg is necessary for patients with mild hepatic impairment. A maximum daily dose of DDR 30 mg 30 mg should be considered for patients with moderate hepatic impairment.