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Fioricet for Pregnancy and Nursing Mom

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Fioricet is known to be a prescription medicine used to treat tension headaches. Well, if you are pregnant and on Fioricet, then there are certain precautions you need to take and you should know about the side effects of Fioricet during pregnancy. You are going through an important phase of your life, when you are carrying a new life inside you. You need to make sure that usage of Fioricet doesn’t harm your unborn baby. Let us learn about the precautions, dosage and care that you need to know while using Fioricet during pregnancy.

Well, if you are using Fioricet during your pregnancy, your doctor should not only consider the benefits of using the drug for you, but also weigh the possible risks to your unborn baby.

You should talk to your doctor as whether you should stop taking drug or need to adjust dose. It is still not known whether acetaminophen, caffeine and butalbital can cause harm to the fetus when recommended to a pregnant women or whether it can affect a woman’s reproduction capacity.

Some studies say that birth defects were observed due to exposure of butalbital during the first three months of pregnancy. Similarly consumption of caffeine during pregnancy has not shown any risks, but high doses of caffeine per day can lead to spontaneous abortion. So if you are pregnant try to minimize the intake of caffeine to avoid risks.

Fioricet consists of caffeine and the risks associated with its consumption in high dosages are miscarriage and poor growth of fetus. Looking at the formulation of Fioricet which consists of caffeine, Acetaminophen and butalbital, acetaminophen is used as antipyretic throughout the pregnancy. Acetaminophen is considered to be safe in pregnancy when taken for short durations in right dosage. Some studies say that use of acetaminophen in pregnant women can reduce the prostacyclin production.

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Since there are inadequate studies available on risks of Fioricet during pregnancy, you can continue using Fioricet during your pregnancy if the benefit is greater than the possible risk to your unborn baby. It is better to speak to your doctor for the right dosage of Fioricet in pregnancy.

Fioricet should be used by pregnant women only when needed. Using it for a long term in high doses can cause harm to your unborn child as it can pre-pone your delivery date. Talk to your doctor to know the risks as well as the benefits.

There are some symptoms that you might experience because of pregnancy like headache, nausea, vomiting etc., if you feel the symptoms are severe, you can speak to your doctor immediately. During pregnancy you need to be extra careful  about the dose of Fioricet and your doctor can help you adjust the dose. Regular check-ups and monitoring unusual symptoms can help you stay away from risks. The drug has its benefits too, so trust your doctor and follow his instructions. Women using Fioricet also deliver healthy babies, so do not panic and take the right dose of Fioricet.

Fioricet should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions.

Laboratory Tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.

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Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital, acetaminophen and caffeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.

Nonteratogenic Effects

Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbitalcontaining drug during the last two months of pregnancy. Butalbital was found in the infant’s serum. The  infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.

Nursing Mothers

Caffeine, barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital, acetaminophen and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

Fioricet or Butalbital APAP Caffeine
Fioricet or Butalbital APAP Caffeine

Geriatric Use

Clinical studies of butalbital, acetaminophen and caffeine capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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Butalbital is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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