Xysedol-spas
Aceclofenac & Drotaverine HCI tablets
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.