Diltiazem Tablets

Description

Diltiazem Tablets

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. manufactures Diltiazem Hydrochloride Tablets in India. Diltiazem is a non-dihydropyridine calcium channel blocker used in selected patients for hypertension and angina, and certain formulations/routes are used for ventricular rate control in atrial fibrillation or flutter. Immediate-release and modified-release products are not automatically interchangeable; indication, dose and dosing frequency depend on the exact registered formulation.

2. Product Specifications

3. Manufacturing Technology

• Immediate-Release Products: Formulation and compression parameters are validated to meet the registered disintegration and dissolution specifications; a universal <15-minute target should not be assumed.
• Modified-Release Products: Where an SR/ER formulation is registered, polymer/matrix or other release-control technology is validated to achieve its specified release profile. A 12-hour duration cannot be inferred from strength alone.
• Coating & Stability: Film coating and packaging systems are selected according to the product's validated formulation and stability requirements.
• Packaging: Blister, Alu-Alu or bottle configurations may be used when supported by stability data and destination-market requirements.

4. Quality Assurance

• Assay & Uniformity: Potency and dosage-unit uniformity are verified against applicable pharmacopoeial/registered limits.
• Dissolution: Immediate- and modified-release products are tested using formulation-specific methods and acceptance criteria rather than universal percentage/time targets.
• Related Substances: Relevant impurities and degradation products are monitored using validated analytical methods.
• Stability: Shelf life and storage conditions are supported by product-specific stability studies.

5. Pharmacology and Clinical Use

Diltiazem inhibits L-type calcium channels in cardiac and vascular smooth muscle. This can reduce vascular resistance and blood pressure, decrease myocardial oxygen demand, dilate coronary arteries and slow AV-nodal conduction.

• Hypertension: Certain oral Diltiazem formulations are used to lower blood pressure.
• Angina: Diltiazem may be used for prevention/management of selected forms of angina; it should not be presented as an immediate self-treatment for an acute chest-pain emergency.
• Atrial Fibrillation / Flutter: Diltiazem can be used for ventricular rate control in selected patients, but route/formulation and clinical setting matter.
• Heart Rate Effects: Because Diltiazem slows AV conduction, bradycardia or conduction block can occur, particularly with other rate-slowing medicines.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where applicable.
• Bioequivalence Documentation: Supplied only where product-specific studies/data are available and required by the destination regulator; not assumed for every modified-release product.
• Certificates: FSC, COPP and COA where applicable.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to applicable requirements.

7. Frequently Asked Questions

Q: Who manufactures Diltiazem Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Diltiazem Hydrochloride tablet formulations in India.

Q: Is Diltiazem available under brand names?
A: Yes. Diltiazem is marketed under multiple brands. A manufacturer's product should only be described as bioequivalent/interchangeable with a particular reference product when supported by required regulatory evidence.

Q: What is the difference between immediate-release and sustained/extended-release Diltiazem?
A: They have different release characteristics and may have different dosing schedules. They should not be interchanged solely on a milligram-for-milligram basis without checking the exact product and prescribing information.

Q: Can Diltiazem be stopped suddenly?
A: Patients should not change or stop prescribed cardiovascular therapy without clinician advice. Whether dose reduction is needed depends on the indication and clinical circumstances; a universal mandatory taper should not be assumed.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Individualized Dosing: Dose and frequency depend on indication and whether the product is immediate- or modified-release. Follow the exact registered prescribing information.
• Modified-Release Tablets: Do not crush, chew or split unless the specific product labeling explicitly permits it, because altering the dosage form may change drug release.
• Administration: Food/timing instructions can differ between products. Follow the label rather than applying a universal “before meals and bedtime” instruction.
• Monitoring: Blood pressure and heart rate should be monitored as clinically appropriate, particularly during dose adjustment or when other rate-slowing medicines are used.

9. Side Effects and Precautions

• Cardiovascular: Bradycardia, hypotension, peripheral edema and AV conduction abnormalities can occur.
• Gastrointestinal / Other: Nausea, constipation, dizziness, headache and fatigue may occur.
• Conduction Disorders: Diltiazem may be contraindicated in certain patients with sick sinus syndrome or second-/third-degree AV block unless an appropriate functioning pacemaker is present; follow the registered label.
• Heart Failure: Negative inotropic effects can be clinically important in some patients with impaired ventricular function; specialist assessment may be needed.
• Drug Interactions: Diltiazem affects CYP3A4/P-glycoprotein and can interact with multiple medicines. Clinically important interactions can include some statins, beta-blockers and Digoxin, but the magnitude and required adjustment vary by drug and patient.

10. Storage Instructions

• Store below 25°C unless otherwise specified on the registered label.
• Protect from excessive light and moisture.
• Keep in original packaging and out of reach of children.