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COMPOSITION:


Each tablet contains:


Pargeverine Hydrochloride ..................... 10,0 mg
(Propinox Hydrochloride)
(Equivalent in Pargeverine ...................... 9,0 mg)

Lysine Clonixinate ......................... 125,0 mg
(Equivalent in Clonixine ......................... 80,3 mg)
Excipients, c.s.p. ...................................... 1 tablet

INDICATIONS:

PLIDOLOR® COMPOUND ( Tablets ) is a spasmolytic (antispasmodic) and analgesic medicine used in the pathogenic and symptomatic therapy of gastrointestinal, hepatobiliary, urinary, or genital spasmolytic syndromes, whichever its degree of intensity and evolution.

CONTRAINDICATIONS:


1. Because of its contents of Pargeverine Hydrochloride : Hypersensitivity to Pargeverine Hydrochloride, glaucoma, urinary retention due to prostate disease and organic pyloric stenosis (see Precautions).

2. Because of its contents of Lysine Clonixinate : Hypersensitivity to Lysine Clonixinate, in patients with active peptic ulcer or gastroduodenal bleeding. Contraindicated during pregnancy and in children under 12. Should not be administered to patients with a history of bronchospasm, nasal polyps, angioedema or urticaria caused by the administration of acetylsalicylic acid or other NSAIDs.
 

PHARMACOLOGY:

The pharmacological action of PLIDOLOR® COMPOUND is due to its active ingredients.

Pargeverine Hydrochloride decreases the tone and motility of the smooth muscle in hollow visceral organs, possessing a slight neurotrophic effect enhancer which, because of its low magnitude, has no atropine side effects. Presents a two-compartment kinetic after intravenous administration : It has a half life of 20 minutes and an elimination of four hours at distribution phase, with an average speed of 30 L / hour. A plasma level is reached within an hour after oral administration, with an average time of absorption of 0.2 hours; the maximum plasma concentration obtained was 150 ng / mL, with an average speed which did not differ from that observed after intravenous administration.

Lysine Clonixinate is an analgesic and nonsteroidal anti-inflammatory (NSAID) which is metabolized in the liver, and excreted in the urine. Inhibits the synthesis of prostaglandins that mediate pain and inflammation, an action that is performed by inhibiting the Cyclooxygenase 2 (COX-2) Enzyme. Pharmacological effect on the Cyclooxygenase 1 (COX-1) Enzyme is less. It is rapidly absorbed after oral administration and metabolized almost entirely and is not accumulated even with continued use. Presents a two-compartment kinetic after intravenous administration. The pharmacokinetics of this active ingredient does not change with age or by the ingested food. Low levels were detected in breast milk.

DRUG INTERACTIONS / FOOD INTERACTIONS:


1. For its content of Pargeverine Hydrochloride : No interactions have been reported with the use of Pargeverine Hydrochloride, but with some drugs in its group : antacids or absorbent antidiarrheals. Simultaneous administration of Pargeverine Hydrochloride with these substances may decrease absorption reducing its therapeutic effectiveness; therefore, it should be administered 2 to 3 hours before or after the intake of any of these drugs. Anticholinergics or other medications with anticholinergic activity, tricyclic antidepressants or monoamine oxidase inhibitors, H 1 antihistamines, except astemizole, cetirizine, loratadine and terfenadine, quinidine, neuroleptics, benztropine , biperidine, budizine, carbamazepine, clozapine, cyclizine, cyclobenzaprine, digoxin, disopyramide, dronabinol, ethopropazine, loxapine, maprotiline, meclizine, olanzapine, oxybutynin, phenothiazines, pinozide, procainamide, procyclidine, thioxanthenes, trihexyphenidyl. In these cases the effects may be increased, and patients should be advised of probable gastrointestinal problems such as paralytic ileus; anti-miastenics : caution is needed because it reduces intestinal motility when used concurrently. Not recommended to be used with atropine, since the muscarinic effects may be the first sign of an overdose of anti-miastenics and, thus may mask such effects with atropine, preventing the early recognition of a cholinergic crisis. The atropine effect of Pargeverine Hydrochloride is minimal.

Ciclopropano: No existen reportes con la asociación de este anestésico, por lo que no debe usarse en forma recurrente haloperidol y bromperidol : si se usa concurrentemente, la actividad antipsicótica de estos fármacos disminuye en pacientes esquizofrénicos.

Ketoconazole : No cases have been reported on its use with Pargeverine Hydrochloride, but it is advisable to space the intake of these drugs by 2 hours between them.

Metoclopramide : Antagonizes the effect of Pargeverine Hydrochloride on gastrointestinal motility.

Narcotic analgesics (opioids): Increase the risk of severe constipation (coming to a paralytic ileus) and / or urinary retention.

Potassium chloride : No cases have been reported, but simultaneous administration is not recommended. Laboratory tests (test on gastric secretion) : The concurrent use of anticholinergics may antagonize the effects of pentagastrin and histamine in this test, it is recommended not to take it 24 hours prior to this test.

2. For its content of Lysine Clonixinate : No interactions have been reported with the use of Lysine Clonixinate, but for some drugs in its group : high-dose acetylsalicylic acid and other nonsteroidal antiinflammatory drugs, alcohol and corticosteroids, colchicine, and potassium supplements : which increase gastrointestinal side effects (bleeding peptic ulcer). Oral anticoagulants, heparin, ticlopidine thrombolytics and platelet aggregation inhibitors : The risk of bleeding may occur; but if the administration is unavoidable, blood coagulation should be checked and the dose adjusted asccording to the results. Valproic acid, cefamadol, cefoperazone, cefotetan plicamycin : Decrease platelet aggregation and increase the risk of bleeding. Insulin and oral antidiabetics : NSAIDs may increase the hypoglycaemic effect of these drugs. Diuretics : Coadministration with diuretics diminishes their natriuretic and antihypertensive effects, which decreases renal blood flow and causes acute renal failure. It is necessary to hydrate dehydrated and diuretic patients before administering Lysine Clonixinate.

Antihypertensive beta-blockers, ACE inhibitors, vasodilators, diuretics : Lose their antihypertensive efficacy due to the inhibition of the synthesis of vasodilator prostaglandins.

Lithium : Increases Plasmatic Lithium concentration. Digitalis glycosides : Increase digoxin concentration in plasma levels, increasing the risk of digitalis toxicity. Methotrexate : Increases the haematological toxicity of methotrexate, and regular tests are strongly recommended. Cyclosporine : Elevates plasmatic level, thus, increasing the risk of nephrotoxicity. Gold salts : Raise the risk of adverse renal effects. Probenecid : Elevates plasmatic levels of some NSAIDs, as well as their side effects, therefore, it is recommended to reduce the dose as soon as the first symptom appears. Alendronate : Increases gastrointestinal side effects : gastrointestinal irritation. Calcium channel blockers may increase the risk of gastrointestinal bleeding. Danaparoid and low molecular weight heparinoid : Raise the risk of bleeding and / or hematoma when when used in neuraxial anesthesia. Eptifibatide : Increases the risk of internal and superficial bleeding because it can cause an increased anticoagulant effect. Ketorolac : Raises the risk of gastrointestinal side effects (peptic ulcer, gastrointestinal bleeding and / or perforation). Levofloxacin and ofloxacin : Increase the risk of stimulation on the central nervous system and may cause claustrophobic seizures (inprisonment). Sulfonylureas : Increase the risk of hypoglycemia. Tacrolimus : May lead to acute renal failure. Laboratory Test : May give false positive results in stool guaiac tests.


PRECAUTIONS :

1. Because of its content of Pargeverine Hydrochloride : Due to its anticholinergic effects, it must be administered with caution in patients prone to urinary or bowel obstruction (specially in high doses). No toxic effects have been reported that could lead to teratogenic, mutagenic or carcinogenic events. Preclinical studies have shown no teratogenic effects during pregnancy, but its use should be avoided during this period (especially the first trimester), unless the specialist considers that the potential benefit to the mother outweighs the risks of its use during gestation. There are no reported studies showing the secretion of this active substance in breast milk while nursing, thus, it should not be administered during this period (in case of administration, the possibility of suspending lactation should be evaluated). No studies have been reported on its pediatric administration or its safe use in newborns and infants, therefore, it should not be administered. It should be administered with caution in elderly patients, because of the risk of precipitating undiagnosed glaucoma. It does not show the effects of anticholinergic drugs at oral level, because it does not modify salivary secretion when recommended doses are administered.

2. Due to its content of Lysine Clonixinate : It should be administered with caution in patients with a history of gastritis and gastroduodenal peptic ulcer, allergy, asthma or are treated with anticoagulants. It is known that NSAIDs in general inhibit the synthesis of prostaglandin which promotes renal irrigation. In patients with decreased renal perfusion, its administration may precipitate decompensation in kidney function which may be irreversible even after stopping taking this drug. Patients susceptible to this complication are patients who are dehydrated and have congestive heart failure, liver cirrhosis, nephrotic syndrome or other kidney diseases, those receiving diuretics, or who have undergone surgery with subsequent hypovolemia, thus, the volume of urine output and renal function must be controlled. It may decrease the effectiveness of antihypertensive medication in hypertensive patients, therefore, blood pressure must be checked regularly. There are no reports of elevated plasmatic levels in transaminases or other liver function parameters (in most cases, the increase over normal levels is small and transient). No studies have been reported in the teratogenicity of Lysine Hydrochloride during pregnancy, thus, it is not recommended to be used during this period. Studies have concluded that small amounts are excreted in breast milk, therefore, the risk-benefit scenario should be assessed if it is required to be administered during lactation. Pediatric studies have not been performed in children 12 and younger, thus, its use is contraindicated in them. It should be administered with caution in elderly patients, because it could affect kidney, liver or heart function.

INCOMPATIBILIDADES:

1. Because of its content of Pargeverine Hydrochloride : Should not be used concurrently with anticholinergic medications or those that could have anticholinergic effects. Furthermore, it should not be used with gastrokinetic drugs.

2. Due to its content of Lysine Clonixinate : Should not be administered together with other nonsteroidal antiinflammatory drugs (high concentrations of acetylsalicylic acid), oral anticoagulants, antihypertensives, diuretics, heparin, thrombolytics, lithium, methotrexate, cyclosporine, ticlopidine, digitalis, gold salts, probenecid (See Drug Interactions).

SIDE EFFECTS:

1. Because of its content of Pargeverine Hydrochloride : It is tolerated in patients who may be sensitive to the active ingredient, even in high doses. It may cause dry mouth or constipation, but can be controlled adjusting the dose.

2. Due to its content of Lysine Clonixinate : It is well tolerated in therapeutic doses and may rarely produce nausea, vomiting, gastritis, dizziness, and drowsiness. It may usually cause skin reactions in predisposed patients.

It may result in inhibition of platelet aggregation, cardiovascular edema or hypotension at blood level. It may also produce euphoria, fatigue, headache, insomnia, tremors, dry mouth, epigastric pain, diarrhea, flatulence, gastrointestinal disturbance, redness, proteinuria, diaphoresis (perspiration), increased body temperature, irritation, itching, pruritus, urticaria and symptoms of influenza.


WARNINGS :

1. Because of its content of Pargeverine Hydrochloride : Clinical studies show that it may cause dry mouth when doses up to 30 mg are administered intravenously as shown in clinical studies; therefore, it is recommended to administer with caution when using high doses.

2. Due to its content of Lysine Clonixinate : It may cause allergic skin or mucosa reactions, peptic ulcer symptoms, gastrointestinal bleeding or bronchospasm; in any of these cases, administration should be discontinued and you should consult your physician immediately.


TREATMENT IN CASES OF OVERDOSE:

There have been no reported overdose cases with PLIDOLOR® COMPOUND or its active ingredients, but, after careful clinical evaluation of the patient from the time of intake of this medicine and contraindication of certain procedures is dismissed, the specialist will decide whether to start recovery treatment : emesis or gastric lavage, administration of activated charcoal and strict clinical control (for possible anticholinergic and gastroduodenal symptoms and signs, and renal function) for which there should be supportive treatment. No specific antidotes have been reported.


DOSIS Y VÍAS DE ADMINISTRACIÓN:
PLIDOLOR® COMPOUND coated tablet :
Adults and children over 12 : 1-2 coated tablets 3 to 4 times daily by mouth. Do not exceed the maximum dose of 6 coated tablets in 24 hours. Swallow coated tablets whole without chewing and with plenty of liquid.

STORAGE CONDITIONS:
Store in a cool, dry place. Keep out of the reach of children.

PRESENTATION:

Box of 20 coated tablets in blisters of 4 tablets.
Box of 100 coated tablets in blisters of 4 tablets.

NOTE:
PLIDOLOR® COMPOUND contains ethylene glycol derivatives, which can have depressant properties and local irritants, thus it must be administered under medical supervision and without exceeding the recommended dose.

Sold under prescription

MASTER FARMA S.A.

Address:

Calle Mariano Odicio 490,
Miraflores,
Lima 18 - Perú

Phone:
+51 (1) 446 1250     
+51 (1) 242 5577

Fax:

+51 (1) 445 7701



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