The combination of Drotaverine and Aceclofenac is a fixed-dose formulation designed to provide relief from pain associated with smooth muscle spasms. Drotaverine, an antispasmodic agent, works by relaxing smooth muscles, while Aceclofenac, a non-steroidal anti-inflammatory drug (NSAID), reduces inflammation and pain. This combination was first approved in India on September 15, 2008, by the Drugs Controller General of India (DCGI) for the treatment of colicky pain due to smooth muscle spasms. Subsequent directives from the DCGI have emphasised the need for active post-marketing surveillance to ensure ongoing safety and efficacy.

This combination is utilised for the treatment of:​

• Abdominal pain​
• Colicky pain due to smooth muscle spasms​
• Pain associated with biliary colic​
• Primary dysmenorrhea (menstrual cramps)

The medication is administered orally in tablet form. The commonly available dosage strength is 80 mg of the antispasmodic agent combined with 100 mg of the NSAID. It is typically taken with food to minimise gastrointestinal discomfort. The exact dosage and duration of treatment should be determined by a healthcare professional based on the patient's condition and response to therapy.​

Common Side Effects:

• Nausea​
• Dizziness
• Headache
• Abdominal discomfort​
• Flatulence​

Serious Side Effects:

• Gastrointestinal bleeding​
• Severe allergic reactions (e.g., rash, itching, swelling)​
• Liver dysfunction (e.g., jaundice)​
• Renal impairment​
• Cardiovascular events (e.g., hypertension, palpitations)​

• Contraindicated in patients with known hypersensitivity to either component.​
• Not recommended for individuals with active gastrointestinal bleeding or peptic ulcers.​
• Should be used cautiously in patients with severe hepatic or renal impairment.​
• Concurrent use with other NSAIDs or anticoagulants may increase the risk of bleeding.​
• Not advised for use during pregnancy or lactation unless deemed essential by a physician.​

Before initiating therapy, a thorough medical history should be obtained to identify any potential contraindications or risk factors. Patients with a history of cardiovascular disease, hypertension, or gastrointestinal disorders should be monitored closely. Regular liver and kidney function tests may be necessary during prolonged use. Patients should be advised to report any unusual symptoms, such as gastrointestinal bleeding or allergic reactions, promptly. It is essential to adhere to the prescribed dosage and not to self-medicate or adjust the dose without consulting a healthcare provider.​

Patients are advised to take this medication exactly as prescribed by their healthcare provider. It should be taken with food to reduce the risk of gastrointestinal side effects. Alcohol consumption should be limited as it may increase the risk of liver damage. Operating heavy machinery or driving should be avoided if dizziness or drowsiness occurs. Regular follow-up appointments are essential to monitor the drug's effectiveness and detect any adverse effects early. Always inform your doctor about all other medications you are taking to avoid potential drug interactions.​

1. https://www.sciencedirect.com/science/article/abs/pii/S0301211510002265
2. Pareek A, Chandurkar NB, Patil RT, Agrawal SN, Uday RB, Tambe SG. Efficacy and safety of aceclofenac and drotaverine fixed-dose combination in the treatment of primary dysmenorrhoea: a double-blind, double-dummy, randomized comparative study with aceclofenac. Eur J Obstet Gynecol Reprod Biol. 2010 Sep;152(1) https://pubmed.ncbi.nlm.nih.gov/20554370/
3. https://go.drugbank.com/drugs/DB06751
4. https://go.drugbank.com/drugs/DB06736

The information on this page is not a substitute for medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you can receive this treatment.