Drug Interaction:
Paracetamol
reduced absorption of chloestyramine within 1 hour of admin.
Accelerated absorption with metoclopromide
Acelofenac may increase plasma conc. of lithium and digoxin Increased nephrotoxicity with diuretics
Serum potassium should be monitored when used with potasium sparing diuretics
May increase plasma methotrexate levels leading to toxicity if administred withi 2 to 4 hrs of methotrexate admin.
Risk of convulsions with quinolones
Paracetamol- Increased risk of liver damage in chronic alcoholics.
increased risk of toxicity with high doses or long term admin of barbiturates, carbamazepine, hydantoins, isonazid, rifampicin, and sulfinpyrazone
Indication:
Approved by US FDA on 06/29/2004- (Ref- FDA approved List- 2004)
For acute painful condition in adults
Pain and inflammation
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1. Aceclofenac 1%w/w Menthol spray Aug 1986
For the treatment of acute painful inflammatory conditions in
adults only
2. Aceclofenanc 100mg + Tizanidine 2mg F.C. tabs 23-02- 09
For the treatment of acute low back pain in adults only
3.Aceclofenac 100mg + paracetamol 500mg tablets 08-07-2004
For acute painful,confitions in adults only
4.Aceclofenac 200mg/200mg SR + Rabeprazole 10mg/ 01-07-2009
20mg capsule
For the treatment of painful inflammatory conditions associated
with gastrointestinal ulcers
5.Aceclofenac gel 1.5% along with liseed oil , menthol, 06-08-2005
Salycilate Capsaicin gel
For pain,swelling etc.
6.Aceclofenac IP (SR pellets ) 200mg/200mg+ 04-01-12
Thiocholchioside IP (SR pellets) 8mg/16mg
Capsules( New dosage Form)
For the treatment of acute inflammation conditions
associated with spasms in adults only
7.Aceclofenac 100mg+ Thiocochicoside 4mg tablets 11-09-2009
( Additional strength)
For the treatment of acute inflammation conditions
associated with spasms only
8.Aceclofenac 100mg + Thiococolchicoside 8mg tablets 03-08-2009
For the treatment of acute inflammation conditions
associated with spasms only
NOT INCLUDED IN FIXED DOSE COMBINATIONS LIST APPROVED BY DCG(I)
Approval status or details not available
.Aceclofenac+Chlorzoxazone + Paracetamol-
Adverse Reaction:
Paracetamol- Nausea, ajllergic reactions, skin rashes Acute renal tubular necrosis
Aceclofenac- Diarrhoea, Headache, vertigo, dizziness, Nervousness, tinnitus, Depression, drowsiness Insomnia, fever , angioedema Brochospas, rashes,
Blood dyscrasias (eg thrombocytopenia, leucopenia, agranulocytosis )
Liver damage Severe GI bleeding, Nephrotoxicity
Contra-Indications:
Hypersensitivity Moderate to severe renal or hepatic impairment severe heart failure pregnancy ( third semester )
Special precautions-
GI diseases, Renal or hepatic impairment, Alcohol -dependent patients
Asthma or allergicdisorders Hemorrhagic disorders,
Hypertension, cardiac impairment Elderly
Caution when driving or operating machinery
Monitor renal and hepatic function and blood counts during long term treatment
Persistently elevated hepatic enzymes levels may require drug withdrawal
Pregnancy Lactation
Dosages/ Overdosage Etc:
Indication
Pain and inflammation
Dosage-
1 tablet in the morning and 1 tablet in the evening 2 tablets a day
Pharmacology/ Pharmacokinetics:
Rationale for combination-
Paracetamol alone does not provide adequate increased analgesic property.
Aceclofenac plays an important role in relieving inflammatory pain, whereas
paracetamol acts on non-inflammatory pain conditions,
Hence a combinaation of these show synergistic action in relieving pain and inflammation
Pregnancy and lactation:
Contraindicated for use during third trimrester of pregnancy
Special precautions to be excercised while adminstering during pregnancy and lactation
Manufacturer Details