Ritodrine

Ritodrine is used to stop premature labor. This medicine was available only with your doctor's prescription.

Ritodrine is no longer available in the United States.

This product is available in the following dosage forms:

• Solution
• Tablet

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

1. Allergies:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

2. Pregnancy:

All Trimesters: Category B: Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

3. Breastfeeding:

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

4. Drug Interactions:

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

5. Other Interactions:

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

6. Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or
• High blood pressure (hypertension), uncontrolled, or
• Migraine headaches (or history of)—May make these conditions worse.
• Heart or blood vessel disease or
• Overactive thyroid, uncontrolled—May cause serious side effects on the heart, including irregular heartbeat.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release capsules):

        o Adults: In the first twenty-four hours after the doctor stops your intravenous ritodrine, your dose may be as high as 40 milligrams (mg) every eight hours. After that, the dose is usually 40 mg every eight to twelve hours. Your doctor may want you to take oral ritodrine up until it is time for you to deliver your baby or until your 37th week of pregnancy.

• For oral dosage form (tablets):

        o Adults: In the first twenty-four hours after the doctor stops your intravenous ritodrine, your dose may be as high as 10 milligrams (mg) every two hours. After that, the dose is usually 10 to 20 mg every four to six hours. Your doctor may want you to take oral ritodrine up until it is time for you to deliver your baby or until your 37th week of pregnancy.

• For injection dosage form:

        o Adults: 50 to 350 micrograms per minute, injected into a vein.

Missed Dose:

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage:

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Check with your doctor right away if your contractions begin again or your water breaks.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems since they may increase the unwanted effects of this medicine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common:

• Blurred vision
• Chest pain or tightness
• Dizziness or lightheadedness
• Drowsiness
• Dry mouth
• Fast or irregular heartbeat—rare with oral form
• Flushed and dry skin
• Fruit-like breath odor
• Increased urination
• Loss of appetite
• Nausea
• Severe pounding or racing heartbeat—rare with oral form
• Shortness of breath—rare with oral form
• Sleepiness
• Stomachache
• Tiredness
• Troubled breathing (rapid and deep)
• Unusual thirst
• Vomiting

Rare:

• Sore throat or fever
• Yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• Fast or irregular heartbeat (severe)
• Nausea or vomiting (severe)
• Nervousness or trembling (severe)
• Shortness of breath (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common:

• Headache
• Reddened skin
• Tremors

Less common or rare:

• Anxiety
• Emotional upset
• Jitteriness, nervousness, or restlessness
• Skin rash

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Shortness of breath

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.