Alneed-Plus
Generic Name
Rabeprazole Sodium + Itopride Hydrochloride
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Description
Overview of the medicine
Alneed-Plus is a combination medication containing Rabeprazole, a proton pump inhibitor (PPI), and Itopride, a prokinetic agent. It is primarily used to treat gastroesophageal reflux disease (GERD), dyspepsia, and other conditions associated with acid reflux and impaired gastrointestinal motility.
Uses & Indications
Dosage
Adults
Usually one capsule once daily, preferably before breakfast. The duration of treatment depends on the condition and physician's assessment.
Elderly
No specific dose adjustment is generally required, but caution is advised in elderly patients, especially those with hepatic or renal impairment.
Renal_impairment
No dose adjustment required for mild to moderate renal impairment. Caution and monitoring advised in severe renal impairment.
How to Take
Alneed-Plus capsules should be swallowed whole with water, preferably before meals (typically before breakfast). Do not chew or crush the capsule.
Mechanism of Action
Rabeprazole inhibits the gastric H+/K+-ATPase (proton pump) in parietal cells, thereby suppressing gastric acid secretion. Itopride enhances acetylcholine release in the gut, which increases gastrointestinal motility and promotes gastric emptying.
Pharmacokinetics
Onset
Acid suppression by Rabeprazole begins within one hour. Itopride's prokinetic effects generally start within 30 minutes to 1 hour.
Excretion
Rabeprazole metabolites are primarily excreted renally. Itopride and its metabolites are mainly excreted in urine.
Half life
Rabeprazole: Approximately 1-2 hours. Itopride: Approximately 6 hours.
Absorption
Rabeprazole is rapidly absorbed, with peak plasma concentrations reached within 2-4 hours. Itopride is also well absorbed orally, with peak plasma concentrations occurring within 0.5-0.75 hours.
Metabolism
Rabeprazole is metabolized primarily by CYP2C19 and CYP3A4. Itopride is extensively metabolized by flavin-dependent monooxygenase (FMO-3) in the liver.
Side Effects
Contraindications
- Hypersensitivity to Rabeprazole, Itopride, or any component of the formulation.
- Known gastrointestinal hemorrhage, mechanical obstruction, or perforation.
Drug Interactions
Digoxin
Increased absorption of digoxin when co-administered with Rabeprazole.
Warfarin
Possible increased INR and bleeding risk with concomitant Rabeprazole use. Monitor INR closely.
Diazepam, Phenytoin
Rabeprazole may prolong the elimination of these drugs due to inhibition of CYP2C19.
Anticholinergic drugs
Itopride's prokinetic effect may be decreased by anticholinergic agents. Avoid concomitant use if possible.
Drugs dependent on gastric pH (e.g., Ketoconazole, Atazanavir)
Rabeprazole can reduce the absorption of these drugs by increasing gastric pH. Dose adjustment or alternative therapy may be necessary.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
In case of overdose, symptomatic and supportive treatment should be initiated. There is no specific antidote. Hemodialysis is not effective in removing Rabeprazole or Itopride from the body.
Pregnancy & Lactation
Pregnancy Category B. Use in pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus. It is not known whether Rabeprazole or Itopride is excreted in human milk; therefore, caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to Rabeprazole, Itopride, or any component of the formulation.
- Known gastrointestinal hemorrhage, mechanical obstruction, or perforation.
Drug Interactions
Digoxin
Increased absorption of digoxin when co-administered with Rabeprazole.
Warfarin
Possible increased INR and bleeding risk with concomitant Rabeprazole use. Monitor INR closely.
Diazepam, Phenytoin
Rabeprazole may prolong the elimination of these drugs due to inhibition of CYP2C19.
Anticholinergic drugs
Itopride's prokinetic effect may be decreased by anticholinergic agents. Avoid concomitant use if possible.
Drugs dependent on gastric pH (e.g., Ketoconazole, Atazanavir)
Rabeprazole can reduce the absorption of these drugs by increasing gastric pH. Dose adjustment or alternative therapy may be necessary.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
In case of overdose, symptomatic and supportive treatment should be initiated. There is no specific antidote. Hemodialysis is not effective in removing Rabeprazole or Itopride from the body.
Pregnancy & Lactation
Pregnancy Category B. Use in pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus. It is not known whether Rabeprazole or Itopride is excreted in human milk; therefore, caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Generally 24 to 36 months from the manufacturing date when stored correctly.
Availability
Available in pharmacies and hospitals nationwide
Approval Status
Approved by local regulatory authorities (e.g., DGDA)
Patent Status
Off-patent (generic versions available)
Clinical Trials
Combination therapies of Rabeprazole and Itopride have demonstrated efficacy in clinical trials for treating GERD and functional dyspepsia, showing superior results compared to monotherapy.
Lab Monitoring
- No routine lab monitoring is generally required.
- Long-term PPI use may necessitate monitoring of Vitamin B12 and Magnesium levels.
Doctor Notes
- Confirm diagnosis before initiating long-term PPI therapy.
- Prescribe the lowest effective dose for the shortest necessary duration.
- Counsel patients on lifestyle modifications to complement drug therapy.
- Be aware of potential drug interactions, especially with narrow therapeutic index drugs.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Swallow the capsule whole; do not chew, crush, or open it.
- Take it preferably before a meal, usually in the morning.
- Do not stop taking the medicine suddenly without consulting your doctor.
- Inform your doctor about all other medications and supplements you are taking.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Alneed-Plus may cause dizziness or drowsiness in some individuals. If you experience these symptoms, avoid driving or operating heavy machinery.
Lifestyle Advice
- Avoid trigger foods and drinks like fatty foods, spicy foods, caffeine, and alcohol.
- Eat smaller, more frequent meals.
- Avoid lying down immediately after eating; wait at least 2-3 hours.
- Elevate the head of your bed to reduce nighttime reflux.
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