Dolalgial 125 Mg 20 Coated Tablets

Dolalgial Clonixino Lysine (125 Mg 20 Coated Tablets)

ACTION AND MECHANISM
Clonixin lysine is a non-steroidal anti-inflammatory drug, with a predominant analgesic action.

PHARMACOKINETICS
- Absorption: Oral absorption is rapid, reaching Cmax in 34-46 minutes.
* Food: They do not modify oral absorption.
- Distribution: Vd: 0.3 liters / kg. The degree of binding to plasma proteins is 96-98%.
- Metabolism: It is metabolized to two hydroxylated metabolites, as well as two more metabolites that have been identified as clonixi-N-oxide and clonixin.
- Elimination: Approximately 74% of clonixin lysine is excreted in urine and 25% in feces. About 90% of the drug is excreted in the urine in conjugated form. The elimination half-life is 1.4-1.9 h.

INDICATIONS
- [PAIN] of mild to moderate intensity.

DOSAGE
- Adults and over 18 years, oral: 125-250 mg / 6-8 h. Maximum dose: 750 mg / day.
If the pain persists for more than 10 days, the clinical situation should be evaluated.
- Elderly: Administer with caution:

DOSAGE IN RENAL INSUFFICIENCY
* Administer with caution.

DOSAGE IN LIVER INSUFFICIENCY
* Administer with caution.

RULES FOR CORRECT ADMINISTRATION
The tablets should be swallowed whole, without breaking or chewing them, with a glass of liquid, preferably with meals or some food.

CONTRAINDICATIONS
Patients with hypersensitivity to clonixin lysine.
- Hematopoietic disorders.
- [PEPTIC ULCER] active.
- Patients with severe kidney failure.
- Patients with a higher tendency to suffer digestive bleeding.
- Children under 12 years old.
- Pregnant or lactating women.

PRECAUTIONS
- Patients with a history of gastrointestinal disturbances, peptic ulcers or inflammatory bowel disease, especially if they use high doses of clonixin lysine (500 mg per day).

- [INFLAMMATORY INTESTINAL DISEASE]. NSAIDs could precipitate symptomatic crisis of diseases such as Crohn's disease or ulcerative colitis, so it is advisable to use with caution, and avoid their use in case of active diseases (See Contraindications).

- [ARTERIAL HYPERTENSION] or [HEART FAILURE]. Clonixin could lead to fluid retention (especially with prolonged use), due to the inhibition of the synthesis of vasodilator prostaglandins, which could worsen these diseases, especially in cases in which there is no previous treatment, or in which he has not been able to control the disease.

- Previous hypersensitivity to [NSAID ALLERGY], history of attacks of [ASTHMA], as well as skin rashes or acute rhinitis.

Although no case has been described during the administration of clonixin lysine, as it is

this drug an NSAIDs, it is recommended to take special precaution in case of:

- Altered kidney function in treatment with NSAIDs, since they may worsen as a consequence of the inhibition of prostaglandin synthesis.

- In patients considered at risk (heart failure, cirrhosis, chronic kidney disease,

dehydration and the elderly), periodic monitoring of serum creatinine and its clearance should be performed.

- Patients with impaired liver function, since NSAIDs could lead to a slight and transient rise in plasma levels of transaminases or other parameters of liver function.

- The use of clonixin lysine can decrease female fertility and its use is not recommended in women trying to become pregnant. In women who have difficulty conceiving or who are under investigation for infertility, discontinuation of treatment with clonixin lysine should be considered.

INTERACTIONS
-Aliskiren: possible reduction of the antihypertensive effect of aliskiren (NSAIDs act on the renin-angiotensin system). In patients with compromised renal function (dehydrated or elderly), deterioration of renal function may be precipitated (possible acute renal failure, usually reversible). Caution, especially in the elderly, monitoring the antihypertensive effect and kidney function.
- SSRI antidepressants (fluoxetine, paroxetine, sertraline, citalopram): there is an increased risk of bleeding in general, and gastrointestinal in particular, especially in the elderly and patients with a history of digestive bleeding.
- Glitazones (pioglitazone, rosiglitazone): theoretical risk of potentiation of edema that both glitazones and NSAIDs can cause. Caution and monitor for signs of fluid retention and heart failure (swollen ankles, dyspnea).
- Methotrexate: there are studies with other non-steroidal anti-inflammatory drugs (ibuprofen, flurbiprofen, ketoprofen, naproxen, piroxicam) in which a possible accumulation of both drugs with potentiation of toxicity has been recorded, due to competition due to the renal excretion mechanism. - Potentially ulcerogenic drugs (alcohol, corticosteroids, other NSAIDs). Avoid co-administration due to the risk of potentiation of its ulcerogenic effects.
- Ticlopidine, heparin administered by the systemic route and thrombolytics: increased risk of
bleeding. If concomitant administration is unavoidable, close
blood coagulation controls should be carried out .
Pharmacokinetics and anticoagulant activity of phenprocoumon.
- Antihypertensive drugs (such as beta-blockers, ACE inhibitors, vasodilators, diuretics): a decrease in hypertensive efficacy has been reported due to inhibition of vasodilator prostaglandins during simultaneous treatment with NSAIDs.
- Diuretics: in dehydrated patients, treatment with NSAIDs increases the potential risk of acute renal failure. In case of concomitant treatment with clonixin lysine and diuretics, patients should be adequately hydrated and renal function monitored before starting it.
- Lithium salts: Possible increase in plasma lithium levels.

PREGNANCY
- Animal studies have not shown teratogenicity. There are no adequate and well-controlled studies in humans.
Prolonged inhibition of fetal prostaglandin synthesis during the first two gestational trimesters has been associated with an increased risk of miscarriage, cardiac malformations (up to 1.5% more than with placebo) and gastroschisis. The risk appears to increase with high doses and prolonged treatments.
Chronic use during the third trimester could theoretically produce premature closure of the ductus arteriosus of the fetus and fetal renal dysfunction with a risk of oligohydroamniosis. In addition, due to its antiplatelet effects, the bleeding time could be prolonged, with possible fetal involvement and risks in childbirth. Another possible effect that could appear is the reduction and even cancellation of uterine contractility, causing an abnormal delay in delivery and a non-physiological prolongation of pregnancy.
It is unknown whether the timely administration of an NSAID could pose a risk to the fetus.
The use of clonixin is not accepted during the first two trimesters of pregnancy. If it has to be used, it will be done at the lowest possible dose and for the shortest possible time. The use of an NSAID in the third trimester is contraindicated.

BREASTFEEDING
Clonixin lysine is excreted in human milk, so the administration of this drug is not recommended during lactation.

CHILDREN
Its use is not recommended in children under 12 years of age.

ELDERLY
The elderly appear to be more susceptible to the adverse effects of NSAIDs. The risk of developing severe ulcer disease is increased in those over 65 years of age, and appears to be dose-dependent. They can also cause fluid retention, which can lead to cardiovascular complications and a reduction in the effectiveness of antihypertensive treatments. It is recommended to use with caution, using the lowest possible effective dose.

Dolalgial Leaflet 125 Mg 20 Coated Tablets