prometrium precautions & warnings

ZapdMom02January 23, 2002

To really get a good grasp on the dangers of Prometrium you should stop by the FDA website for & check out the Physicians Fact Sheet. Had I known that there was such a huge difference between the Patients Fact List and the Physicians, I would NEVER have begun to take the Prometrium. I suffer from Secondary Amenorhea and took Prometrium for 4mo. I gained 30lbs & became increasingly depressed with crying spells and intense anxiety. I already suffer from depression and it diminished the effectiveness of my current meds. I don't know why my doctor didn't inform me. But she didn't. I am going OFF the Prometrium on the advice of my Psychiatrist. What I mean to say is BE WELL INFORMED BEFORE YOU TAKE ANY MEDICATION. Read below.

The most common adverse experiences reported in 5% of patients in all PROMETRIUM Capsules dosage groups studied in this trial(100 mg/day to 400 mg/day) were: dizziness(16%) breast pain(11%), headache(10%), abdominal pain(10%), fatigue(9%), viral infection(7%), abdominal distention(6%), musculoskeletal pain(6%), emotional lability(6%),

irritability(5%), upper respiratory tract infection (5%)

PRECAUTIONS - General

-Patients who have a history of psychic depression should be carefully observed & the drug discontinued if the depression recurs to a serious degree.

-The pretreatment physical examination should include special reference to breast & pelvic organs, & Pap smear.

-Because progesterone may cause some degree of fluid retention, conditions which might be influenced by this factor, such as epilepsy, migraine, asthma, cardiac or renal dysfunction, require careful observation.

-In cases of breakthrough bleeding, as in any cases of irregular bleeding per vaginum, nonfunctional causes should be borne in mind. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures are indicated.

-Any possible influence of prolonged progestin therapy on pituitary, ovarian, adrenal, hepatic or uterine functions awaits further study.

-Although concomitant use of conjugated estrogens & PROMETRIUM Capsules did not result in a decrease in glucose tolerance, diabetic patients should be carefully observed while receiving estrogen-progestin therapy.

-The pathologist should be advised of progestin therapy when relevant specimens are submitted.

-Because of the occurrence of thrombotic disorders (thrombophlebitis, pulmonary embolism, retinal thrombosis, & cerebrovascular disorders) in patients taking estrogen-progestin combinations, the physician should be alert to the earliest manifestation of these disorders.

-Transient dizziness may occur in some patients. Use caution when driving a motor vehicle or operating machinery. A small percentage of women may experience extreme dizziness and/or drowsiness during initial therapy. For these women, bedtime dosing is advised.

WARNINGS

-The physician should be alert to the earliest signs of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, & retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately.

-Discontinue medication pending examination if there is sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn.

-The administration of any drug to nursing mothers should be done only when clearly necessary since many drugs are excreted in human milk. Detectable amounts of progestin have been identified in the milk of mothers receiving progestins. The effect of this on the nursing infant has not been determined

-Retrospective studies of morbidity & mortality in Great Britain & studies of morbidity in the United States have shown a statistically significant association between thrombophlebitis, pulmonary embolism, cerebral thrombosis & embolism, & the use of oral contraceptives.

-The estimate of the relative risk of thromboembolism in the study by Vessey & Doll was about seven fold, while Sartwell & associates in the U.S. found a relative risk of 4.4, meaning that the users are several times as likely to undergo thromboembolic disease without evident cause as nonusers.

-The American study also indicated that the risk did not persist after discontinuation of administration, & that it was not enhanced by long-continued administration. The American study was not designed to evaluate a difference between products.

Other adverse events reported in -Autonomic Nervous System Disorders: dry mouth

-Body As A Whole: accidental injury, chest pain, fever

-Cardiovascular System Disorders: hypertension

-Central & Peripheral Nervous System Disorders: confusion, somnolence, speech disorder

-Gastrointestinal System Disorders: constipation, dyspepsia, gastroenteritis, hemorrhagic rectum, hiatus hernia, vomiting

-Hearing & Vestibular Disorders: earache

-Heart Rate & Rhythm Disorders: palpitation

-Metabolic & Nutritional Disorders: edema, edema peripheral

-Musculoskeletal System Disorders: arthritis, leg cramps, hypertonia, muscle disorder, myalgia

-Myo/Endo/Pericardial & Valve Disorders: angina pectoris

-Psychiatric Disorders: anxiety, impaired concentration, insomnia, personality disorder

-Reproductive System Disorders: leukorrhea, uterine fibroid, vaginal dryness, fungal vaginitis, vaginitis

-Resistance Mechanism Disorders: abscess, herpes simplex

-Respiratory System Disorders: bronchitis, nasal congestion, pharyngitis, pneumonitis, sinusitis

-Skin & Appendages Disorders: acne, verruca, wound debridement

-Urinary System Disorders: urinary tract infection

-Vision Disorders: abnormal vision

-White Cell & Resistance Disorders

The following adverse experiences have been reported with PROMETRIUM Capsules in other U.S. clinical trials: increased sweating, asthenia, tooth disorder, anorexia, increased appetite, nervousness, & breast enlargement.

The following additional adverse experiences have been observed in women taking progestins in general: breakthrough bleeding, spotting, change in menstrual flow, amenorrhea, changes in the cervical squamo-columnar junction & cervical secretions, changes in weight(MORE or LESS), jaundice, anaphylactoid reactions & anaphylaxis, rash (allergic) with & without pruritus, melasma or chloasma, pyrexia, & insomnia.

Luck,Wendy

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