Instructions for Pentalgin
Release form Pentalgin:
Film-coated tablets
Description Pentalgin:
Film-coated tablets from light green to green, biconvex, in the form of a capsule with beveled edges, scored on one side and embossed "PENTALGIN" on the other; on a cut a tablet is light green with a color with white blotches.
1 tab.
paracetamol 325 mg
naproxen 100 mg
caffeine 50 mg
drotaverine hydrochloride 40 mg
pheniramine maleate 10 mg
Excipients:
microcrystalline cellulose - 128 mg
potato starch - 55.38 mg
croscarmellose sodium - 32 mg
hyprolose (hydroxypropyl cellulose) - 32.52 mg
citric acid monohydrate - 3 mg
butylhydroxytoluene (E321) - 0.3 mg
magnesium
stearate - 7.2 mg
talc - 16.12 mg
quinoline yellow dye (E104) - 0.4608 mg
indigo carmine (E132) - 0.0192 mg.
Clinical and pharmacological groups Pentalgin:
Spasmodic analgesic
Active substance Pentalgin:
caffeine
paracetamol
drotaverine hydrochloride
naproxen
pheniramine maleate
Pharmaco-therapeutic group Pentalgin
Analgesic agent (NSAIDs + non-narcotic analgesic agent + psychostimulant agent + antispasmodic agent + H1-histamine receptor blocker)
pharmachologic effect Pentalgin:
The combined preparation has an analgesic, anti-inflammatory, antispasmodic, antipyretic effect.
Paracetamol is an analgesic-antipyretic, has antipyretic and analgesic effects due to the blockade of COX in the central nervous system and the effect on the centers of pain and thermoregulation.
Caffeine is a psychostimulant that causes dilation of blood vessels in skeletal muscles, heart, kidneys; increases mental and physical performance, helps to eliminate fatigue and drowsiness; increases the permeability of histohematogenous barriers and increases the bioavailability of non-narcotic analgesics, thereby enhancing the therapeutic effect. Has a tonic effect on the vessels of the brain.
Drotaverine - has a myotropic spasmolytic effect due to inhibition of PDE 4, acts on the smooth muscles of the gastrointestinal tract, biliary tract, genitourinary system, blood vessels.
Pheniramine is a blocker of histamine H 1 receptors. It has an antispasmodic and mild sedative effect, reduces exudation phenomena, and also enhances the analgesic effect of paracetamol and naproxen.
Indications Pentalgin:
- pain syndrome of various origins
- joint pain
- muscle pain
- sciatica
- algodismenorrhea
- neuralgia
- toothache
- headache (including those caused by cerebral vasospasm)
- incl. joint pain
- muscle pain
- sciatica
- algodismenorrhea
- neuralgia
- toothache
- headache (including those caused by cerebral vasospasm)
- pain syndrome associated with spasm of smooth muscles
- incl. with chronic cholecystitis
- gallstone disease
- postcholecystectomy syndrome
- renal colic
- post-traumatic and postoperative pain syndrome
- accompanied by inflammation
- colds accompanied by a febrile syndrome (as symptomatic therapy).
- Acute upper respiratory tract infection, unspecified
- Other specified changes in the teeth and their supporting apparatus (including toothache)
- Gallstone disease [cholelithiasis] (including hepatic colic)
- Chronic cholecystitis
- Postcholecystectomy syndrome
- Joint pain
- Radiculopathy
- Sciatica
- Lumbago with sciatica
- Myalgia
- Unspecified neuralgia and neuritis
- Renal colic, unspecified
- Primary dysmenorrhea
- Secondary dysmenorrhea
- Fever of unknown origin
- Headache
- Sharp pain
- Other persistent pain (chronic)
- Dislocation, stretching and overstrain of the capsular-ligamentous apparatus of the joint of an unspecified area of the body
Method of application Pentalgin:
The drug Pentalgin is administered orally, 1 tab. 1-3 times / day The maximum daily dose is 4 tab.
The duration of treatment is no more than 3 days as an antipyretic agent and no more than 5 days as a pain reliever. Continuation of drug treatment is possible only after consulting a doctor.
Do not exceed the indicated dose of the drug Pentalgin.
Overdose Pentalgin:
Symptoms: pallor of the skin, anorexia (lack of appetite), abdominal pain, nausea, vomiting, gastrointestinal bleeding, agitation, restlessness, confusion, tachycardia, arrhythmia, hyperthermia (fever), frequent urination, headache, tremors or muscle twitching; epileptic seizures, increased activity of hepatic transaminases, hepatonecrosis, increased prothrombin time. Symptoms of liver dysfunction may appear 12-48 hours after an overdose. In severe overdose, hepatic failure develops with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis; arrhythmia, pancreatitis. If you suspect an overdose, you should immediately seek medical help.
Drug interactions Pentalgin:
At the same time taking the drug Pentalgin ® with barbiturates, tricyclic antidepressants, rifampicin, ethanol increases the risk of hepatotoxicity (these combinations should be avoided).
Paracetamol enhances the effect of indirect anticoagulants and reduces the effectiveness of uricosuric drugs.
Long-term use of barbiturates reduces the effectiveness of paracetamol.
With the simultaneous use of paracetamol with ethanol, the risk of acute pancreatitis increases.
Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxic effects of paracetamol.
With simultaneous use with diflunisal, the plasma concentration of paracetamol increases by 50%, which increases the risk of developing hepatotoxicity.
With the combined use of caffeine and barbiturates, primidone, anticonvulsants (hydantoin derivatives, especially phenytoin), it is possible to increase metabolism and increase the clearance of caffeine; while taking caffeine and cimetidine, oral contraceptives, disulfiram, ciprofloxacin, norfloxacin - a decrease in the metabolism of caffeine in the liver (slowing down its excretion and increasing its concentration in the blood).
The simultaneous use of caffeinated beverages and other drugs that stimulate the central nervous system can lead to overstimulation of the central nervous system.
With the simultaneous use of drotaverine can weaken the antiparkinsonian effect of levodopa.
With the simultaneous use of pheniramine with tranquilizers, hypnotics, MAO inhibitors, ethanol, it is possible to increase the inhibitory effect on the central nervous system.
Application during pregnancy and lactation Pentalgin:
The drug Pentalgin is contraindicated for use during pregnancy.
If necessary, use of the drug during lactation should stop breastfeeding.
Side effect Pentalgin:
Allergic reactions: skin rash, itching, urticaria, angioedema.
From the hematopoietic system: thrombocytopenia, leukopenia, agranulocytosis, anemia, methemoglobinemia.
From the side of the central nervous system: agitation, anxiety, increased reflexes, tremors, headache, sleep disturbances, dizziness, decreased concentration.
From the side of the cardiovascular system: palpitations, arrhythmias, increased blood pressure.
From the digestive system: erosive and ulcerative lesions of the gastrointestinal tract, nausea, vomiting, epigastric discomfort, abdominal pain, constipation, liver dysfunction.
From the urinary system: impaired renal function.
From the senses: hearing loss, tinnitus, increased intraocular pressure in patients with angle-closure glaucoma.
Others: dermatitis, tachypnea (rapid breathing).
If any of the side effects indicated in the instructions are aggravated, or the patient notes any other side effects not specified in the instructions, he should inform the doctor about it.
Contraindications for use Pentalgin:
erosive and ulcerative lesions of the gastrointestinal tract in the acute phase;
gastrointestinal bleeding;
complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history);
severe liver failure;
severe renal failure;
oppression of bone marrow hematopoiesis;
condition after coronary artery bypass grafting;
severe organic diseases of the cardiovascular system (including acute myocardial infarction);
paroxysmal tachycardia;
frequent ventricular premature beats;
severe arterial hypertension;
hyperkalemia;
pregnancy;
lactation period (breastfeeding);
children and adolescents up to 18 years old;
hypersensitivity to drug components.
The drug should be used with caution in patients with cerebrovascular diseases, diabetes mellitus, peripheral arterial disease, history of gastrointestinal ulcers, with mild or moderate renal and hepatic insufficiency, viral hepatitis, alcoholic liver damage, benign hyperbilirubinemia (Gilbert's, Dubin's syndromes) Johnson and Rotor), epilepsy, with a tendency to seizures, deficiency of glucose-6-phosphate dehydrogenase, in elderly patients.
In the presence of any of the listed diseases and conditions, the patient should consult a doctor before using the drug Pentalgin.
