Index
It is a drug that works to treat spasms and as a pain reliever.
Another name for this drug is Compound Sertal.
Indications
Its therapeutic action is aimed at treating and controlling spasmodic syndromes of gastrointestinal, hepatobiliary, urinary or genital origin, whatever their degree of intensity and evolution.
Each coated tablet contains 125 mg lysine clonixinate, 10 mg propinox.
Excipients:
- Microcrystalline cellulose.
- Cornstarch.
Pharmacological characteristics / properties
Propinox is an antimuscarinic anticholinergic agent, a tertiary amine synthetic derivative, with antispasmodic action at the smooth muscle level, and lysine clonixinate is a non-steroidal anti-inflammatory analgesic – antipyretic.
This drug has an inhibitory action on cyclooxygenase and consequently on the synthesis of prostaglandins that mediate pain perception.
Pharmacokinetics
After administration of a parenteral dose, the plasma half-life of lysine clonixinate and propinox is approximately 1 hour.
Lysine clonixinate is extensively metabolized, eliminating more than 60% of the administered dose in the urine, while propinox is mostly excreted in the urine in unchanged form.
Dosage and method of administration
For adults and children over 12 years : 1 to 2 coated tablets 3 to 4 times per day without exceeding the maximum total dose of 6 tablets daily.
Swallow the tablets whole, without chewing.
Contraindications
It is advisable to abstain from their employment in case of:
- Allergy or hypersensitivity to the active principles.
- Pregnancy and breastfeeding.
- Active peptic ulcer or gastroduodenal hemorrhage.
- Organic pyloric stenosis.
- Paralytic ileus.
- Megacolontóxico
- Prostate hypertrophy.
- Glaucoma.
- Miastenia serious.
It should not be administered in patients with a history of bronchospasm induced by non-steroidal anti-inflammatory drugs.
Warnings
As with other anticholinergic drugs, drowsiness, dizziness and blurred vision may occur, of which those patients who drive vehicles or operate machinery should be warned.
In individuals particularly sensitive to anticholinergics, episodes of psychosis with manifestations such as confusion, disorientation, agitation, insomnia , hallucinations, dysarthria and ataxia have been reported rarely , which usually remit between 12 and 48 hours after stopping the medication.
Precautions
It should be used with caution in patients with:
- Autonomic neuropathy.
- Hyperthyroidism
- Severe coronary artery disease or heart failure.
- Uncontrolled hypertension.
- Cardiac arrhythmias.
Long-term effects during continued use include:
- Inhibition of platelet aggregation with prolongation of bleeding time.
- Worsening of gastroesophageal reflux.
- Irritation of the digestive mucosa.
- Gastrointestinal ulcer.
- Renal function disorders.
Adverse effects due to cholinergic blockade may be aggravated when other antimuscarinic drugs, amantadine, haloperidol, phenothiazines, imao, tricyclic antidepressants, and some antihistamines are used together.
In the same way as with other non-steroidal anti-inflammatory drugs, interactions with hypoglycemic drugs or oral anticoagulants can occur.
Lactation
It is not known whether lysine clonixinate and propinox are excreted through breast milk, therefore their use in breastfeeding women is not recommended. Pediatric use: the safety and efficacy of lysine clonixinate and propinox in children has not yet been established. under 12 years of age, so its use in this age group is not recommended.
Side effects
- In the digestive system: occasionally it can have the effect of a dry throat and mouth, constipation, a sensation of gastric fullness or fullness, epigastric pain or heartburn. It can rarely cause nausea, vomiting, and gastritis.
- In the nervous system: rarely headache, drowsiness or sedation, dizziness, vertigo, ataxia, insomnia, confusion and / or excitability (especially in geriatric patients).
- On the skin: occasionally decreased sweating, and rarely urticaria and idiosyncratic allergic reactions.
- In the urinary system: occasionally decreased force of the voiding stream and rarely urinary retention (especially in the presence of obstructive uropathies).
- At the cardiovascular level: tachycardia and palpitations may rarely occur.
- At the ocular level: occasionally mydriasis and blurred vision; rarely increased pressure in the eye.
- In the blood: in high doses and prolonged treatments, a decrease in platelet aggregability may occasionally be evidenced.
Overdose
No cases of untreated overdose have yet been reported. The signs and symptoms that could occur in case of overdose are:
- Headache.
- Frequent nausea and vomiting.
- Dilated pupils.
- Hot and dry skin.
- Dry mouth
- Arrhythmias
- Vertigo.
- Confusion and symptoms of stimulation of the central nervous system.
Guiding initial treatment of overdose
After careful clinical evaluation of the patient, the evaluation of the time elapsed since the administration and ruling out the contraindication of certain procedures, neostigmine can be used subcutaneously or intravenously 0.5 mg up to a maximum of 2 mg.
Severe symptoms of arousal can be managed with sodium thiopental 2% solution by slow intravenous route. General care measures and medical procedures must always be carried out to maintain the airway, oxygenation and control of vital signs.
In the event of an overdose, go to the nearest hospital.
