Rispain Plus

Diclofenac Sodium BP & Lidocaine Hydrochloride USP
Anti-inflammatory & Analgesic

Rispain Plus

Description

Composition:

Rispain Plus IM Injection: Each 2 ml contains sterile Diclofenac Sodium BP 75 mg and Lidocaine Hydrochloride USP 20 mg.

Pharmacology:

Diclofenac is a potent NSAID having both strong anti-inflammatory & analgesic properties. It inhibits synthesis of prostaglandin from arachidonic acid by blocking the cycloxygenase enzyme.

 

Indications:

Rheumatology: Inflammatory and degenerative forms of rheumatism, chronic involutive, polyarthritis, ankylosing spondylarthritis, osteoarthritis, spondylarthroses, acute gout, peri-articular rheumatic disorders.
Surgery and Traumatology: Sprain, bruises, dislocations, fractures, soft-tissue injuries, surgical interventions.
Obstetrics and Gynecology: Primary dysmenorrhoea, episiotomy, adnexitis, endometritis, parametritis, salpingitis, and mastitis.
Otorhinolaryngology: As pre-operative medication for the prevention of pain, inflammation, and swelling.
Dentistry: Post-operative and post-traumatic pain, inflammation, and swelling.
Other indications: For the prevention of pain and treatment of inflammation and swelling of patients operated in the urogenital tract, renal and biliary colic.

 

Dosage & Administration:

Rispain Plus injections are intended for intramuscular injection.
Adults: The dosage is generally one 75 mg ampoule daily. In severe cases (e.g. colic) the daily dose can exceptionally be increased to two ampoules of 75 mg, separated by an interval of a few hours. Alternatively, one ampoule of 75 mg can be combined with other dosage forms (tablets, suppositories) up to a maximum daily dosage of 150 mg.
In migraine attacks, clinical experience is limited to initial use of 1 ampoule of 75 mg administered as soon as possible, followed by suppositories up to 100 mg on the same day if required. The total dosage should not exceed 175 mg on the first day.

Children: In juvenile chronic arthritis, 1-3 mg of Diclofenac sodium/kg body weight daily in divided doses.
Elderly patients: The lowest effective dosage is recommended, commensurate with age and physical status or as prescribed by the physician.

Contraindication:

It is contra-indicated for those patients who are hypersensitive to Diclofenac. In patients with active or suspected peptic ulcer or gastrointestinal bleeding, or for those patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other NSAIDs possessing prostaglandin synthetase inhibitinig activity, it is also contraindicated.
Because of the presence of Lidocaine, it is also contraindicated for those patients who are hypersensitive to local anaesthetics of the amide type, although the incidence is very rare.

 

Warning & Precaution:

History of gastrointestinal ulceration, haematemesis or melaena, ulcerative colitis, Asthma or history of asthma, Crohn\’s disease, bleeding diathesis or haematological abnormalities. Patients with severe hepatic, cardiac or renal insufficiency or the elderly people, Current or previous high blood pressure ( hypertension) should be kept under close surveillance. All patients who are receiving long-term treatment with NSAID agents should be monitored as a precautionary measure (e.g., renal, hepatic function and blood counts).If abnormal liver function tests persist or worsen, clinical signs and symptoms consistent with liver disease develop or if other manifestations occur, Diclofenac sodium should be discontinued. Use of Diclofenac tablet in patients with hepatic porphyria may trigger an attack.

 

Side Effects:

Side-effects of Diclofenac is usually mild and transient. It is generally well tolerated. At the starting of the treatment, however, patients may sometimes complain of gastrointestinal discomfort, epigastria pain, eructation, nausea and Diarrhoea, headache and bleeding sometime may occur. Occasionally skin rash, peripheral oedema and abnormalities of serum transaminase have been reported.Very rarely reported side effects include activation of peptic ulcer, haematemesis or melena, blood dyscrasia (extensive usage). There have been isolated reports of anaphylactoid reactions.
The adverse effects due to Lidocaine mainly involve the CNS, are usually of short duration, and are dose related. The CNS reaction may be manifested by drowsiness, dizziness, disorientation, confusion, lightheadness, etc.

Pregnancy and Lactation:

Pregnancy: It should not be prescribed during pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used. These types of drugs are not recommended during the last trimester of pregnancy.
Lactation: Very small quantities of Diclofenac may be detected in breast milk, but no undesirable effects on the infant are to be expected.

 

Storage:

Store in a cool and dry place, protected from light.

 

Packing:

Rispain plus IM Injection: Each box contains 6 ampoules of 2 ml.