Hyperlipen: Indications, Contraindications, Adverse Reactions, Interactions and Warning

Hypocholesterolemic medication indicated for the treatment of primary hyperlipidemias.

Indications

Recommended for the treatment of primary dyslipoproteinemias, including types IIa, IIb, III and IV (hypercholesterolemia, hypertriglyceridemia and combined forms), refractory to appropriate dietary treatment. Dietary measures should be continued during therapy.

Contraindications of Hyperlipen

  • Severe hepatic insufficiency
  • Severe renal failure.
  • Pregnancy and lactation.
  • Concurrent use with another fibrate.
  • Hypersensitivity to the active substance or to any component of the product.

Adverse reactions:

  • Skin disorders: Skin reactions have been reported mainly allergic; rashes, urticaria and pruritus, and very rarely photosensitivity. As with other drugs in this class, a low incidence of alopecia has been reported.
  • Muscle disorders:   as with other fibrates, serum creatine phosphokinase (CPK) elevation, myalgia, and myopathy have been reported , including myositis and rare cases of rhabdomyolysis .

In most cases, muscle toxicity is reversible when treatment is withdrawn. Neurological disorders: occasional reports of headache, vertigo.

Dizziness and drowsiness were rarely reported in association with ciprofibrate. As with other drugs of this class, a low incidence of impotence has been reported.

Gastrointestinal disorders

There have been occasional reports of gastrointestinal symptoms that include nausea, vomiting, diarrhea, dyspepsia, and abdominal pain. In general, these side effects were mild to moderate in nature and occurred at the beginning, becoming less frequent as the treatment progressed.

  • Hepatobiliary disorders: As with other fibrates, abnormal liver function tests have occasionally been observed. Very rare cases of cholestasis or cytolysis have been reported . Exceptional cases with chronic evolution have been observed.
  • Pulmonary disorders: Isolated cases of pneumonitis or pulmonary fibrosis have been reported.
  • General disorders: fatigue has rarely been reported in association with ciprofibrate.

Interactions of the Hyperlipen

Other fibrates: As with other fibrates, the risk of rhabdomyolysis and myoglobinuria may be increased if ciprofibrate is used in combination with other fibrates.

Inhibitors of HMG CoA reductase: as with other fibrates, the risk of myopathy, rhabdomyolysis, and myoglobinuria may be increased if ciprofibrate is used in combination with HMG CoA reductase inhibitors. The benefits of combined use must be weighed carefully against the risks.

Physicians contemplating concomitant treatment with HMG CoA reductase inhibitors should consult the relevant HMG CoA reductase inhibitor, as some higher doses are contraindicated / not recommended with fibrates.

Oral anticoagulant therapy:  Ciprofibrate is highly bound to proteins and, therefore, is likely to displace other drugs from plasma protein binding sites.

Ciprofibrate has been shown to potentiate the effect of warfarin , indicating that concomitant therapy with oral anticoagulants should be administered at reduced doses and adjusted according to the INR.

Warnings

Patients with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose or galactose malabsorption should not take this medicine.

Patients should be advised to report unexplained muscle pain, tenderness or weakness immediately. CPK levels should be evaluated immediately in patients who report these symptoms.

Treatment should be discontinued if the CPK levels are higher than ten times the upper limit of the normal range, if the levels increase progressively or if there is other evidence of myopathy. Doses of 200 mg of ciprofibrate per day or more have been associated with a high risk of rhabdomyolysis.

Therefore, the daily dose should not exceed 100 mg. Impaired renal function and any situation of hypoalbuminemia such as nephrotic syndrome, high alcohol intake or hypothyroidism may increase the risk of myopathy.

As with other fibrates, the risk of rhabdomyolysis and myoglobinuria may be increased if ciprofibrate is used in combination with other fibrates or HMG CoA reductase inhibitors.

Use with caution in patients with hepatic insufficiency. Periodic liver function tests are recommended.

Treatment with ciprofibrate should be discontinued if there are significant abnormalities in transaminases or if cholestatic liver damage is evident. Secondary causes of dyslipidemia, such as hypothyroidism , should be excluded or corrected before starting any lipid-lowering drug therapy.

Special precautions for use with oral anticoagulant therapy: concomitant therapy with oral anticoagulants should be administered in reduced doses and adjusted according to INR.