Xysedol-spas

Aceclofenac & Drotaverine HCI tablets

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Aceclofenac

Acenac is a non-steroidal agent with antiinflammatory and analgesic properties. Its mode of action is largely based on inhibition of prostaglandin synthesis. Acenac is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandins. It also stimulates cartilage matrix (glycosaminoglycans) synthesis.

Dose :

ADULT - 200 MG DAILY IN TWO DEVIDED DOSES

Monograph :

Aceclofenac tablet Presentation Acenac : Each film-coated tablet contains Aceclofenac BP 100 mg. Description Acenac is a non-steroidal agent with antiinflammatory and analgesic properties. Its mode of action is largely based on inhibition of prostaglandin synthesis. Acenac is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandins. It also stimulates cartilage matrix (glycosaminoglycans) synthesis. Indications and Uses Acenac is indicated for the relief of pain and inflammation in both acute and chronic pain like osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, dental pain, post-traumatic pain, low back pain, gynaecological pain etc. Dosage and Administration Adults: The maximum recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening. Children: There is no clinical data on the use of aceclofenac in children. Elderly: The pharmacokinetics of aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose and dose frequency. Renal insufficiency: There is no evidence that the dosage of aceclofenac needs to be modified in patients with mild renal impairment. Hepatic insufficiency: The dose of aceclofenac should be reduced in patients with hepatic impairment. An initial daily dose of 100 mg should be administered. Side effects Generally aceclofenac is well tolerated. The majority of side effects observed have been reversible and of a minor nature and include gastrointestinal disorders (dyspepsia, abdominal pain, nausea and diarrhoea) and occasional occurance of dizziness. Dermatological side effects including pruritus and rash. Abnormal hepatic enzyme levels and raised serum creatinine have occasionally been reported. Contraindications Aceclofenac is contraindicated in patients previously sensitive to aceclofenac or aspirin or other NSAIDs. It should not be administered to patients with active or suspected peptic ulcer or gastrointestinal bleeding and moderate to severe renal impairment. Precautions Aceclofenac should be administered with caution to patients with symptoms indicative of gastrointestinal disorders, with a history of peptic ulceration, ulcerative colitis, Crohn's disease, hepatic porphyria, and coagulation disorders. Patients suffering from severe hepatic impairment must be monitored. Use in pregnancy & lactation Pregnancy: There is no information on the use of aceclofenac during pregnancy. Aceclofenac should not be administered during pregnancy, unless there are compelling reasons for doing so. The lowest effective dose should be administered. Lactation: There is no information on the secretion of aceclofenac in breast milk. The use of aceclofenac should therefore be avoided during lactation unless the potential benefits to the mother outweigh the possible risks to the children. Drug interactions Lithium and Digoxin: Aceclofenac, like other NSAIDs, may increase plasma concentrations of lithium and digoxin. Diuretics: Aceclofenac, like other NSAIDs, may inhibit the activity of diuretics. Anticoagulants: Like other NSAIDs, Aceclofenac may enhance the activity of anticoagulants. Quinolones: Convulsion may occur due to an interaction between quinolones and NSAIDs. Other NSAIDs and steroids: Concomitant therapy with aspirin, other NSAIDs and steroids may increase the frequency of side effects. Overdosage There is no human data available on the consequences of aceclofenac overdosage. After overdosage, following therapeutic measures to be taken: absorption should be prevented as soon as possible by means of gastric lavage and treatment with activated charcoal. Supportive and symptomatic treatment should be given for complications. Commercial Pack Acenac : Each box contains 10 blister strips of 10 tablets. Aceclofenac has no specific interaction information. Aceclofenac belongs to NSAIDs and will have the following interactions of NSAIDs: Interactions do not generally apply to topical NSAIDs ACE Inhibitors Antagonism of hypotensive effect and increased risk of renal impairment Adrenergic Neurone Blockers Antagonism of hypotensive effect Alpha-blockers Antagonism of hypotensive effect Angiotensin-II Receptor Antagonists Antagonism of hypotensive effect and increased risk of renal impairment with NSAIDs Antidepressants, SSRI Increased risk of bleeding Aspirin (also Benorilate) Avoid concomitant administration (increased side-effects) Baclofen Possibly reduced excretion of baclofen (possibly increased risk of toxicity) Beta-blockers Antagonism of hypotensive effect Since systemic absorption may follow topical application of beta-blockers to the eye the possibility of interactions, in particular, with drugs such as verapamil should be borne in mind Calcium-channel Blockers Antagonism of hypotensive effect Cardiac Glycosides Possibly exacerbation of heart failure, reduced GFR, and increased plasma-cardiac glycoside concentrations Ciclosporin Increased risk of nephrotoxicity Clonidine Antagonism of hypotensive effect Clopidogrel Increased risk of bleeding Corticosteroids Increased risk of gastro-intestinal bleeding and ulceration Interactions do not generally apply to corticosteroids used for topical action (including inhalation) Coumarins Anticoagulant effect possibly enhanced Change in patient's clinical condition, particularly associated with liver disease, intercurrent illness, or drug administration, necessitates more frequent testing. Major changes in diet (especially involving salads and vegetables) and in alcohol consumption may also affect anticoagulant control Diazoxide Antagonism of hypotensive effect Diuretics Risk of nephrotoxicity of NSAIDs increased; antagonism of diuretic effect Diuretics, Potassium-sparing Possibly increased risk of hyperkalaemia Drospirenone Possible hyperkalaemia (monitor serum potassium during first cycle) Heparins Possibly increased risk of bleeding Hydralazine Antagonism of hypotensive effect Ketorolac Avoid concomitant use (increased risk of side-effects and haemorrhage) Lithium Probably reduced excretion of lithium (risk of toxicity) Methotrexate Excretion of methotrexate probably reduced (increased risk of toxicity) Methyldopa Antagonism of hypotensive effect Mifepristone Manufacturer of mifepristone recommends avoid NSAIDs on theoretical grounds Minoxidil Antagonism of hypotensive effect Moxonidine Antagonism of hypotensive effect Nitrates Antagonism of hypotensive effect Nitroprusside Antagonism of hypotensive effect NSAIDs Avoid concomitant use (increased side-effects) Interactions do not generally apply to topical NSAIDs NSAIDs Avoid concomitant use (increased side-effects) Interactions do not generally apply to topical NSAIDs Pentoxifylline (oxpentifylline) Possibly increased risk of bleeding Phenindione Possibly enhanced anticoagulant effect Change in patient's clinical condition particularly associated with liver disease, intercurrent illness, or drug administration, necessitates more frequent testing. Major changes in diet (especially involving salads and vegetables) and in alcohol consumption may also affect anticoagulant control Phenytoin Effect of phenytoin possibly enhanced Quinolones Possibly increased risk of convulsions Ritonavir Plasma concentration possibly increased by ritonavir Sulphonylureas Possibly enhanced effect of sulphonylureas Tacrolimus Possibly increased risk of nephrotoxicity Zidovudine Increased risk of haematological toxicity Increased risk of toxicity with nephrotoxic and myelosuppressive drugs - for further details consult product literature Aceclofenac belongs to Analgesics but Analgesics has no interactions information

Drotaverine HCI

DROTAVERINE IS AN ISOQUINOLINE DERIVATIVE, IT DOSE NOT MASK SIGNS & SYMPTOMS OF A SERIOUS ILLNESS SUCH AS AN ACUTE ABDOMEN SO THAT DIAGNOSIS IS NOT MISSED. DROTAVERIN is a musculotropic antispasmodic drug acting directly on smooth muscle cells. DROTIN produces smooth muscle relaxation particularly where spasm exists. The action does not involve the autonomic nervous system, hence DROTIN is free from anticholinergic like side effects. DROTIN can be administered to patients suffering from glaucoma and prostatic hypertrophy when anticholinergic antispasmodics are contraindicated.

Dose:

THE USUAL DOSE :- ADULTS : 40-80 MG THRICE DAILY. CHILDREN :- 1-5 YEARS: 20 MG, 3-4 TIMES DAILY 6-12 YEARS: 40 MG, THRICE DAILY.

Monograph :

Drotaverine PRESENTATION: Each DROTIN tablet contains 40 mg Drotaverine Hydrochloride. Each DROTIN DS tablet contains 80 mg Drotaverine Hydrochloride. Each DROTIN Injection 2 ml ampoule contains 40 mg Drotaverine Hydrochloride. INDICATIONS: Tablet : Spastic conditions of the gastrointestinal tract : Biliary colic and spastic conditions of the biliary tract ; cholelithiasis, choledolithiasis, cholecystitis ; Renal colic and spastic conditions of the urogenital tract ; nephrolithiasis, ureterolithiasis, Dysmenorrhea, Post-MTP and D&C. Infection : As an emergency antispasmodic medicine for acute gastrointestinal colics, biliary colics, renal colics and severe dysmenorrhea. Hastening cervical dilatation during normal vaginal delivery. DOSAGE: Tablets: Adults(Abovel2years) : DROTIN DS one tablet 3 times a day. Children between 1 to 6 years : DROTIN half tablet 3 times a day. Children between 6 to 12 years : DROTIN one tablet 3 times a day. Injection: For acute colics in adults; one to two ampoules of Drotin Injection I M/ slow intravenous (IV) upto three times a day. In labour (Active phase of first stage at three (3) cm cervical dilatation or more); one ampoule of Drotin Injection to be administered intramuscularly (I M), which can be repeated after -two-hourly intervals. USE IN PREGNANCY: As indicated by animal reproductive studies and supported by more than 30 years of usage, Drotaverine has shown no significant increase in congenital anomalies. Thus Drotaverine can be said to have no embryotoxic or teratogenic effects. ADVERSE REACTIONS; Too rapid intravenous injections should be avoided in order to prevent drop in arterial blood pressure. In rare cases, nausea and vertigo may occur after rapid IV Injection. DRUG INTERACTIONS: Levodopa (Antiparkinson effect may decrease) FURTHER INFORMATION: DROTIN is a musculotropic antispasmodic drug acting directly on smooth muscle cells. DROTIN produces smooth muscle relaxation particularly where spasm exists. The action does not involve the autonomic nervous system, hence DROTIN is free from anticholinergic like side effects. DROTIN can be administered to patients suffering from glaucoma and prostatic hypertrophy when anticholinergic antispasmodics are contraindicated.