Aceclofenac + Paracetamol + Rabeprazole Pharmacology
Aceclofenac + Paracetamol + Rabeprazole
Distribution: Aceclofenac: >99.7% bound to plasma proteins; distributes into synovial fluid. Paracetamol: Distributes throughout most fluids of the body.
Metabolism: Aceclofenac: Probably metabolised by CYP2C9; average plasma elimination half-life: 4-4.3 hr. Paracetamol: Mainly metabolised hepatically; plasma elimination half-life: 1-4 hr.
Excretion: Aceclofenac: About two-thirds of the administered dose is removed in the urine, mainly as conjugated hydroxymetabolites. Paracetamol: Most metabolites are removed in the urine within 24 hr.
2.Allergic reactions
3Skin rashes
4.Acute renal tubular necrosis.
5.Diarrhoea
6. Headache
7.Vertigo
8.Dizzies
9.Nervousness
10.Tinnitus
11.Drowsiness
12.Insomnia
13.Fever
14.Angioedema
15.Bronchospasm
16.Rashes
17.Blood dyscrasias
Potentially Fatal:
Paracetamol: Very rare, blood dyscrasias (eg, thrombocytopaenia, leucopaenia, neutropaenia, agranulocytosis); liver damage.
Aceclofenac: Severe GI bleeding; nephrotoxicity.
Elderly:Caution when driving or operating machinery. Monitor renal and hepatic function and blood counts during long term treatment. Persistently elevated hepatic enzyme levels may require drug withdrawal.
Aceclofenac: M0ay increase the plasma concentrations of lithium and digoxin. Increased nephrotoxicity with diuretics. Serum-potassium should be monitored when used with potassium-sparing diuretics. May enhance activity of anticoagulants. May increase plasma methotrexate levels leading to toxicity if administered within 2-4 hr of methotrexate admin. Risk of convulsions with quinolones.
Potentially Fatal: Paracetamol: Increased risk of liver damage in chronic alcoholics. Increased risk of toxicity with high doses or long term admin of barbiturates, carbamazepine, hydantoins, isoniazid, rifampin and sulfinpyrazone.
Aceclofenac
1. It inhibits cyclooxygenase (COX) activity and to suppress the PGE2 production by inflammatory cells, by inhibiting IL-Beta & TNF in the inflammatory cells (Intracellular Action).
2. It blocks degeneration and stimulates synthesis of extra cellular matrix of cartilages by inhibiting the action of different cytokines.
3. Drug and its metabolites inhibit IL-6 production by human chondrocytes. This leads to inhibition of increase of inflammatory cells in synovial tissue, inhibition of IL-1 amplification, inhibition of increased MMP synthesis and thus ensuring proteoglycan production.
4. It inhibits IL-1 and TNF production by human chondrocytes, inflammatory cells and synovial cells and therefore blocks suppression of GAG and collagen synthesis and stimulates growth factors mediated synthesis of GAG and collagen.
5. 4`-hydroxyaceclofenac a metabolite of aceclofenac inhibits pro MMP1 and pro MMP3 produced by synovial cells (Rheumatoid Synovial Cells) in serum and in synovial fluid and thus inhibits progressive joint destruction by MMPs.
6. Aceclofenac inhibits Neutrophil Adhesion & Accumulation at the inflammatory site in the early phase and thus blocks the pro-inflammatory actions of Neutrophils.
7. Aceclofenac is also an NSAID with greater COX-2 specificity
Distribution- Widely distributed in the body as protein-bound form. It is highly protein-bound (>99.7%). Aceclofenac penetrates into the synovial fluid, where the concentrations reach approximately 60% of those in plasma.
Metabolism- Metabolized into metabolites in the liver. Main metabolite is 4-hydroxyaceclofenac
Excretion- It is excreted through urine mainly as conjugated hydroxymetabolites
2. Abdominal pain
3. Dizziness
4. Vertigo
5. Pruritis
6. Rash
7. Dermatitis
8. Nausea
9. Diarrhoea
10. Flatulence
11. Gastritis
12. Constipation
13. Vomiting
14. Ulcerative stomatitis
15. Elevation of circulating levels of hepatic enzymes.
2. Bleeding from the stomach or intestines
3. Moderate to severely decreased kidney function
4. Hypersensitivity to other NSAIDs
5. Active peptic ulcer
2. Bleeding tendencies
3. Blood disorders
4. Crohn`s disease
5. Decreased heart function
6. History of peptic ulcers
7. Inflammation of the bowel and back passage
8. Mildly decreased kidney function
9. Recent major surgery
10. Stomach disorders
11. Decreased liver function
12. Intestinal disorders
2. Osteoarthritis
3. Symptomatic treatment of pain and inflammation in Post-Traumatic pain
4. Cervical pain
5. Low back pain
6. Acute gout
Anticoagulants: Activity of anticoagulants may be increased.
Diuretics : Aceclofenac inhibits the activity of diuretics. When concomitantly administrated with potassium sparing diuretics, serum potassium should be monitored.
Cyclosporin: Aceclofenac may enhance cyclosporin nephrotoxicity.
Quinolones : Aceclofenac may precipitate convulsions when coadministered with quinolone antibiotics.
Adult (general dose)-
100mg twice daily
Paracetamol
It is more active on cyclo-oxygenase enzyme in brain. Peripherally it is a poor inhibitor of prostaglandin synthesis.
Analgesic action: Paracetamol raises the pain threshold and produces analgesic effect.
Antipyretic action: Paracetamol lowers fever by direct action on the thermoregulatory centre in the Hypothalamus and block the effects of endogenous pyrogen.
Distribution: It is distributed mostly in the body in unbound form.
Metabolism: It is extensively metabolised in the liver.
Excretion: Excreted in the urine.
2. Abdominal distress
3. Allergic reactions
4. Rash
2. Renal impairment
3. Hypertension
NEONATES : Contraindicated
2. Acute gout
3. Migraine
Charcoal: Activated, administered immediately reduces absorption of paracetamol.
Domperidone and metochlopramide: Enhance absorption of paracetamol.
Alcohol: Chronic excessive ingestion of alcohol potentiates hepatotoxicity of paracetamol.
Zidovudine: Effects zidovudine may be decreased.
500 - 1000 mg in 3 times daily
Maximum dose: 4 g / day
For migraine: 500 mg to be taken at the first sign of migraine attack and repeated 4 - 6 hourly until suppress mild attacks.
Children:
60 mg / kg body weight /day in 4 divided doses.
Maintenance dose: 75 mg / kg orally every 4 - 6 hours for 2 - 3 days. Haemodialysis can be done in emergency conditions.
Rabeprazole
2. Nausea
3. Headache
4. Vomiting
5. Abdominal pain
6. Dizziness
7. Flatulence
8. Constipation
9. Dyspepsia
10. Flu like syndrome
11. Insomnia
12. Back pain
13. Cough
14. Rhinitis
15. Pharyngitis
16. Rash
2. Monitor gastric malignancy
NEONATES: Contraindicated
2. Benign Gastric ulcer
3. Zollinger- Ellison syndrome
4. Erosive Gastroesophageal reflux disease
Digoxin : Increase in trough digoxin levels in normal subjects.
Adult: 10 - 20 mg / day drug to be taken before breakfast.
Duodenal ulcer: 20 mg / day in the morning for 1 month if needed dose can be continuing for 1more month.
Benign Gastric ulcer: 20 mg / day in the morning for 6 weeks if needed dose can be continuing for 6 more weeks.
Zollinger- Ellison syndrome: Initial dose: 60 mg / day if needed increase the dose up to 120 mg / day in 2 divided doses.
Erosive Gastroesophageal reflux disease: 20mg / day for 1-2 months.
Gastroesophageal reflux disease long term management: 10-20 mg once daily before breakfast for 1 year
Children: not recommended
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