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FDA Alerts

Special Alerts:

[Posted 01/17/2008] FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#cough and http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm.

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cyproheptadine
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(si proe HEP ta deen)

What is this medicine?

CYPROHEPTADINE is a antihistamine. This medicine is used to treat allergy symptoms. It is can help stop runny nose, watery eyes, and itchy rash.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • any chronic disease
  • glaucoma
  • prostate disease
  • ulcers or other stomach problems
  • an unusual or allergic reaction to cyproheptadine, other medicines foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed. Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

This medicine may also interact with the following medications:
  • alcohol
  • barbiturate medicines for inducing sleep or treating seizures
  • medicines for depression, anxiety or psychotic disturbances
  • medicines for movement abnormalities
  • medicines for sleep
  • medicines for stomach problems
  • some medicines for cold or allergies

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Tell your doctor if your symptoms do not improve or if they get worse. You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks. Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe. This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe. This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • agitation, nervousness, excitability, not able to sleep
  • chest pain
  • irregular, fast heartbeat
  • pain or difficulty passing urine
  • seizures
  • unusual bleeding or bruising
  • unusually weak or tired
  • yellowing of the eyes or skin
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

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