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Abbott Receives U.S. Food and Drug Administration Approval for New Lower-Strength Kaletra(R) (lopinavir/ritonavir) Tablet for Pediatric HIV Patients
Date:11/12/2007

e taken by patients who have had an allergic reaction to KALETRA or any of its ingredients.

Taking KALETRA with certain drugs can cause serious problems or death. KALETRA must not be taken with dihydro-ergotamine, ergonovine, ergotamine, or methylergonovines such as Cafergot(R), Migranal(R), D.H.E. 45(R), ergotrate maleate, and methergine, as well as Halcion(R) (triazolam), Orap(R) (pimozide), Propulsid(R) (cisapride), or Versed(R) (midazolam).

KALETRA must not be taken with rifampin, also known as Rimactane(R), Rifadin(R), Rifater(R), or Rifamate(R); St. John's wort (Hypericum perforatum); Mevacor(R) (lovastatin), or Zocor(R) (simvastatin).

There are drug-drug interactions with the potential for risk of serious or life-threatening side effects. Alterations in dose, increased monitoring of drug levels in the blood, or increased observations for side effects may be recommended when KALETRA is taken with: Lipitor(R) (atorvastatin), Crestor(R) (rosuvastatin), Viagra(R) (sildenafil), Cialis(R) (tadalafil), Levitra(R) (vardenafil), oral contraceptives ("the pill") or the contraceptive patch, Mycobutin(R) (rifabutin), inhaled Flonase(R) (fluticasone), metronidazole, or disulfiram. Patients should talk with their doctor about all medicines they are taking or planning to take, including those without a prescription and herbal products.

KALETRA should not be given once-daily in combination with Sustiva(R) (efavirenz), Viramune(R) (nevirapine), Agenerase(R) (amprenavir), fosamprenavir, Viracept(R) (nelfinavir), phenobarbital, phenytoin (Dilantin(R)) or carbamazepine (Tegretol(R)).

Patients and/or their care providers should pay special attention to accurate administration of the KALETRA dose to reduce the risk of accidentally giving too much or too little medicine.

The most commonly reported side effects of moderate severity that are thought to be drug related are abdominal pain, abnormal bowel movements, diarrhea, feeling weak/tired, heada
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SOURCE Abbott
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