(Drug Name) (Drug Form) (Drug Strength)
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Pramipexole: Oral tablet, extended release (0.75mg)

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In-Depth Information

Pramipexole Dihydrochloride 0.75mg Extended-Release Tablet

NDC: 103700252
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Parkinson's Disease

Storage Information
Dispense in original container or USP equivalent tight container
Store at controlled room temperature (between 68 and 77 degrees F)
Avoid excessive humidity
Pramipexole Dihydrochloride 0.75mg Extended-Release Tablet

Reported Side Effects for Pramipexole Dihydrochloride 0.75mg Extended-Release Tablet

Flu Incidence:
<7.0%*
Severity: MILD
Onset: DELAYED
Infection Incidence:
<4.0%*
Severity: MILD
Onset: DELAYED
Restlessness Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Dyskinesia Incidence:
<47.0%*
Severity: MODERATE
Onset: DELAYED
Postural Low Blood Pressure Incidence:
<53.0%*
Severity: MODERATE
Onset: DELAYED
Stuffy Nose Incidence:
<6.0%*
Severity: MILD
Onset: EARLY
Dystonic Reaction Incidence:
<8.0%*
Severity: MODERATE
Onset: DELAYED
Extra Saliva Production Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Excessive Mucle Tone Incidence:
<7.0%*
Severity: MODERATE
Onset: DELAYED
Depression Incidence:
<2.0%*
Severity: MODERATE
Onset: DELAYED
Abnormal Dreams Incidence:
1.0-11.0%*
Severity: MILD
Onset: EARLY
Rapid Muscle Twitches Incidence:
1.0%*
Severity: MODERATE
Onset: DELAYED
Weakness Incidence:
1.0-14.0%*
Severity: MILD
Onset: DELAYED
Muscle Weakness Incidence:
1.0%*
Severity: MODERATE
Onset: DELAYED
Double Vision Incidence:
1.0%*
Severity: MILD
Onset: EARLY
Decreased Sexual Desire Incidence:
1.0%*
Severity: MILD
Onset: DELAYED
Decreased Appetite Incidence:
1.0-5.0%*
Severity: MILD
Onset: DELAYED
Loose Stools Incidence:
1.0-7.0%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
1.0-4.0%*
Severity: MILD
Onset: EARLY
Fever Incidence:
1.0%*
Severity: MILD
Onset: EARLY
Weight Loss Incidence:
2.0%*
Severity: MILD
Onset: DELAYED
Skin Rash Incidence:
2.0%*
Severity: MILD
Onset: EARLY
Paranoia Incidence:
2.0%*
Severity: MILD
Onset: EARLY
Feeling Sick Incidence:
2.0-3.0%*
Severity: MILD
Onset: EARLY
Impotence (erectile Dysfunction) Incidence:
2.0%*
Severity: MODERATE
Onset: DELAYED
Uncontrolled Urination Incidence:
2.0%*
Severity: MODERATE
Onset: EARLY
Fluid Retention Incidence:
2.0-8.0%*
Severity: MODERATE
Onset: DELAYED
Back Pain Incidence:
2.0-3.0%*
Severity: MILD
Onset: DELAYED
Difficulty Swallowing Incidence:
2.0%*
Severity: MODERATE
Onset: DELAYED
Balance Problems Incidence:
2.0-4.0%*
Severity: MILD
Onset: EARLY
Causing To Be Hungry Incidence:
2.0-3.0%*
Severity: MILD
Onset: DELAYED
Cough Incidence:
3.0%*
Severity: MILD
Onset: DELAYED
Sudden Sleep Onset Incidence:
3.0-6.0%*
Severity: MODERATE
Onset: DELAYED
Muscle Cramps Incidence:
3.0-5.0%*
Severity: MILD
Onset: DELAYED
Visual Impairment Incidence:
3.0%*
Severity: SEVERE
Onset: EARLY
Rhinitis Incidence:
3.0%*
Severity: MILD
Onset: EARLY
Stomach Pain Incidence:
3.0-4.0%*
Severity: MILD
Onset: EARLY
Dry Mouth Incidence:
3.0-7.0%*
Severity: MILD
Onset: EARLY
Chest Pain Incidence:
3.0%*
Severity: MODERATE
Onset: EARLY
Lightheadedness Incidence:
3.0-26.0%*
Severity: MILD
Onset: EARLY
Shaking Incidence:
3.0%*
Severity: MILD
Onset: EARLY
Hypoesthesia Incidence:
3.0%*
Severity: MILD
Onset: DELAYED
Tired Incidence:
3.0-9.0%*
Severity: MILD
Onset: EARLY
Shortness Of Breath Incidence:
4.0%*
Severity: MODERATE
Onset: EARLY
Vomiting Incidence:
4.0%*
Severity: MILD
Onset: EARLY
Headache Incidence:
4.0-16.0%*
Severity: MILD
Onset: EARLY
Inability To Sleep Incidence:
4.0-27.0%*
Severity: MILD
Onset: EARLY
Loss Of Memory Incidence:
4.0-6.0%*
Severity: MODERATE
Onset: DELAYED
Swelling Incidence:
4.0-5.0%*
Severity: MODERATE
Onset: DELAYED
Confusion Incidence:
4.0-10.0%*
Severity: MODERATE
Onset: EARLY
Constipation Incidence:
4.0-14.0%*
Severity: MODERATE
Onset: DELAYED
Hallucinations Incidence:
5.0-17.0%*
Severity: MODERATE
Onset: EARLY
Increased Urination Incidence:
6.0%*
Severity: MILD
Onset: EARLY
Drowsiness Incidence:
6.0-36.0%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
11.0-28.0%*
Severity: MILD
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Daily Life Interactions for Pramipexole Dihydrochloride 0.75mg Extended-Release Tablet

Elements of your daily lifestyle may have an effect on the medications you are taking. Drug interactions can result in unwanted side effects, reduce the effectiveness of your medicine or possibly increase the action of a particular medicine.

Major Lifestyle Interaction
Alcohol and Pramipexole Dihydrochloride 0.75mg Extended-Release Tablet(Pramipexole Dihydrochloride)
Alcohol and Pramipexole Dihydrochloride(Pramipexole Dihydrochloride)
Avoid the ingestion of Alcoholic beverages while taking Pramipexole. Alcohol may increase the risk of excessive sedation (difficulty staying awake or other side effects of Pramipexole), or may increase the risk of an accident.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Avoid - This drug is known to cause harm to infants when taken by nursing mothers.


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