Usage
Drotaverine + Ranitidine is prescribed for the relief of spasms and pain associated with functional gastrointestinal disorders, such as irritable bowel syndrome and biliary dyskinesia. It is also used to treat peptic ulcers and gastroesophageal reflux disease (GERD).
Pharmacological Classification:
- Drotaverine: Antispasmodic
- Ranitidine: H2 receptor antagonist
Mechanism of Action:
Drotaverine is a direct smooth muscle relaxant, primarily acting on the gastrointestinal tract. Ranitidine decreases stomach acid production by blocking histamine H2 receptors in the stomach lining. The combination provides both antispasmodic and antacid effects.
Alternate Names
No widely recognized alternate names exist for the combination product itself. However, the individual components may be known by other names.
Brand Names: Ranispas-DV, Averine R
How It Works
Pharmacodynamics:
Drotaverine directly inhibits phosphodiesterase activity, increasing intracellular cyclic AMP, leading to smooth muscle relaxation. Ranitidine competitively inhibits histamine at H2 receptors of gastric parietal cells, reducing gastric acid secretion.
Pharmacokinetics:
Drotaverine is well-absorbed orally. Ranitidine is also absorbed orally, with bioavailability reduced by food. Both drugs are metabolized in the liver and excreted primarily through the kidneys. Specific details on CYP enzyme involvement are not readily available for this drug.
Mode of Action: Drotaverine acts directly on smooth muscle, whereas ranitidine acts on H2 receptors in the stomach.
Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation:
- Drotaverine: Phosphodiesterase inhibition
- Ranitidine: Competitive inhibition of histamine at H2 receptors.
Elimination Pathways:
Both are primarily excreted renally, with some hepatic metabolism. More detailed pathways and CYP enzyme information is not available.
Dosage
Standard Dosage
Adults:
Oral: One tablet (Drotaverine 40mg + Ranitidine 150mg) two to three times a day. Dosages may vary based upon the indication and severity of symptoms.
Children:
Information regarding specific pediatric dosing for this fixed-dose combination is limited. Drotaverine dosing is sometimes based on age, with adjustments as needed. Ranitidine pediatric dosing is generally weight-based. Consult specialized pediatric resources for accurate dosing guidelines.
Special Cases:
- Elderly Patients: Dose adjustment may be needed due to decreased renal function.
- Patients with Renal Impairment: Ranitidine dose reduction is necessary in patients with creatinine clearance less than 50 mL/min.
- Patients with Hepatic Dysfunction: Caution is advised; dose adjustments may be needed for both drugs.
- Patients with Comorbid Conditions: Consider individual patient conditions and adjust accordingly.
Clinical Use Cases
The combination is not typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, or ICU. Ranitidine alone, especially in IV form, might be utilized for stress ulcer prophylaxis in critically ill patients. However, drotaverine is not typically employed in those situations.
Dosage Adjustments
Adjustments are based on individual patient conditions, especially renal and hepatic function. Consult a specialist for complex cases or comorbidities.
Side Effects
Common Side Effects:
Headache, dizziness, nausea, constipation, diarrhea, dry mouth.
Rare but Serious Side Effects:
Rarely, allergic reactions including skin rash, itching or swelling, and difficulty breathing.
Long-Term Effects:
Limited data is available on the long-term effects.
Adverse Drug Reactions (ADR):
Report any suspected ADRs promptly to the appropriate authorities.
Contraindications
Hypersensitivity to either drotaverine or ranitidine. Porphyria (for drotaverine). Severe renal or hepatic impairment. Use cautiously in pregnancy and breastfeeding.
Drug Interactions
Antacids may reduce the absorption of ranitidine. Drotaverine can potentiate the effects of levodopa. Ranitidine may interact with drugs metabolized by the liver. Consult a comprehensive drug interaction resource for a complete list.
Pregnancy and Breastfeeding
Use with caution during pregnancy and breastfeeding. Ranitidine is excreted in breast milk. Drotaverine’s effects during these periods are not well-studied. Consult a specialist before prescribing.
Drug Profile Summary
- Mechanism of Action: Drotaverine: smooth muscle relaxant, Ranitidine: H2 receptor antagonist
- Side Effects: Headache, dizziness, nausea, constipation, diarrhea, dry mouth
- Contraindications: Hypersensitivity, porphyria, severe organ impairment
- Drug Interactions: Antacids, levodopa, other hepatic metabolism drugs
- Pregnancy & Breastfeeding: Use cautiously under specialist guidance.
- Dosage: Adults: One tablet two-three times a day. Individual adjustments necessary.
- Monitoring Parameters: Monitor renal and hepatic function, especially in patients with pre-existing conditions.
Popular Combinations
This fixed-dose combination itself is a popular pairing for addressing abdominal pain with an acid component.
Precautions
Assess for allergies and pre-existing conditions. Exercise caution in special populations.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Drotaverine + Ranitidine?
A: One tablet (Drotaverine 40 mg + Ranitidine 150 mg) two or three times a day for adults. Pediatric and special population dosing requires individualized assessment.
Q2: What are the primary uses of this combination?
A: Primarily indicated for abdominal pain associated with functional gastrointestinal disorders and acid-related issues such as peptic ulcers.
Q3: What is the difference between drotaverine and ranitidine?
A: Drotaverine is an antispasmodic, directly relaxing smooth muscle. Ranitidine is an H2 blocker, reducing stomach acid.
Q4: Can pregnant or breastfeeding women use this medication?
A: Use with caution and only under specialist guidance.
Q5: Are there any specific dietary restrictions while on this medication?
A: No specific dietary restrictions are typically necessary. However, food may affect ranitidine absorption.
Q6: What should a patient do if they miss a dose?
A: Take the missed dose as soon as remembered, unless it is nearly time for the next dose. Do not double the dose.
Q7: Can this drug be used long-term?
A: Discuss long-term use with a physician to assess benefits and risks.
Q8: What are the signs of an allergic reaction to this medication?
A: Signs may include rash, itching, swelling, difficulty breathing, dizziness, or lightheadedness. Seek immediate medical attention if any of these occur.
Q9: How does this drug interact with alcohol?
A: Alcohol may affect the efficacy of both components. It is generally recommended to limit alcohol consumption while taking the medication.
