Medicines & You

= Chemical Compound
= Indications
= Dosage
= Contraindication
= Special Precautions
= Adverse Reactions
= Drug-Drug Interaction

Hormones

a) Androgens & Related Synthetic Drugs

Testosterone undecanoate.
Testosterone replacement therapy in male hypogonadal disorders.
Prostatic or mammary carcinoma.
Overt cardiac failure, renal dysfunction, hypertension, epilepsy, migraine; prepuberty.
Fluid & electrolyte retention; priapism, signs of excessive sexual stimulation, oligospermia, decreased ejaculatory vol. In prepubertal buys, precocious sexual development, premature epiphyseal closure, increased frequency of erections, phallic enlargement.

Mesterolone.
Disorders due to androgen deficiency eg reduced efficiency in middle & advanced age, potency disturbances, infertility, hypogonadism. For use in male patients only.
Prostatic carcinoma; previous or existing liver tumours.
Regular exam of the prostate. Use in male patients only. Benign & rarely, malignant liver tumours which may lead to life-threatening intra-abdominal hemorrhage have been observed. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be taken into consideration.
If frequent or persistent erections occur, reduce dose or discontinue treatment.

Per mL – Testosterone propionate 30mg, testosterone phenylpropionate 60 mg, testosterone isocaproate 60 mg, testosterone decanoate 100mg.
Testosterone replacement therapy in male hypogonadal disorders. Osteoporosis due to androgen deficiency.
Known or suspected prostatic or mammary carcinoma.
Latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy. Migraine; prepuberty.
Priapism, signs of excessive sexual stimulation, oligospermia, decreased ejaculatory vol; fluid & salt retention. In prepubertal boys, precocious sexual development, increased frequency of reactions, phallic enlargement, premature epiphyseal closure.

Testosterone enanthate.
In men: Hypogonadism, potency disorders, male climacteric, aplastic anaemia. In women: supplementary therapy in progressive mammary carcinoma in the postmenopause.
Prostatic carcinoma, history of or existing hepatic tumor (in progressive mammary carcinoma only, if they are not due to metastases), mammary carcinoma in males.
Regular exam of the prostate. Benign & rarely, malignant liver tumours which may lead to intra-abdominal hemorrhage have been observed. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be taken into consideration. Development of hypercalcaemia in female patients 9stop treatment).
Edema; sings of virilisation in women (acne, hirsutism, voice changes), inhibition of spermatogenesis. If frequent or persistent erections occur, reduce dose or discontinue treatment.

b) Oestrogens & Progesterones & Related Synthetic Drugs

11 tab each containing – Estradiol valerate 2 mg. 10 tab each containing – Estradiol valerate 2mg, cyproterone acetate 1 mg.
Hormonal replacement therapy in climacteric complaints, signs of involution of the skin & urogenital tract, depressive moods in the climacteric, deficiency symptoms after overiectomy for non-carcinomatous diseases; prevention of postmenopausal osteporosis.
Severe disturbances of liver function; jaundice or persistent itching during a previous pregnancy; previous or existing liver tumours; uterine, ovarian or breast tumours or a suspicion of such tumours, endometriosis; existing or previous thromboembolic processes; severe diabetes mellitus w/ vascular changes; sickle-cell anemia; disturbances of lipo-metabolism; history of herpes of pregnancy; otosclerosis w/ deterioration during pregnancy; pregnancy, lactation.
Discontinue therapy if migraine occur for the 1st time or if there is more frequent occurrence of unusually severe headache; sudden perceptual disorders 9eg disturbances of vision or hearing); 1st signs of thrombophlebitis or thromboembolic symptoms; a feeling of pain & tightmess in the chest; pending operations (6 wk beforehand); immobilization (eg following accidents); onset of jaundice or hepatitis; generalized pruritus; increase in epileptic seizures; significant rise in BP; pregnancy. Close supervision of patients suffering from diabetes, hypertension, varicose veins, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany or chorea minor & women w/ a history of phlebitis.
Occasionally, a feeling of tension in the breasts, intermenstrual bleeding, GI complaints, nausea, changes in body wt & libido.
Barbiturates, hydantoins, phenylbutazone, rifampicin, ampicillin. Requirement for oral antidiabetics & insulin can change.

Dydrogesterone.
Dysmenorrhoea, Endometriosis, dysfunctional bleeding, premenstrual syndrome/ infertility due to luteal insufficiency/ irregular cycles, threatened abortion, habitual abortion, postmenopausal complaints (HRT)
Breast & genital cancers; abnormal vag bleeding.
Breakthrough bleeding (increase dosage).

Bromocriptine mesylate.
Prolactin-dependent menstrual cycle disorders & female infertility, polycystic ovary syndrome, supplement to anti-oestrogens in anovulatory cycles, premenstrual symptoms, male hyperprolactinaemia, prolactinomas, acromegaly, mastalgia & other forms of benign breast disease, Parkinson’s disease.
Toxemia of pregnancy, hypertension postpartum & during puerperium.
Postpartum & puerperal women w/ high BP, coronary artery disease, or psychic disorders; concomitant use of other ergot alkaloid. Fertility may be restored (contraception needed if conception is not desired); luteal function impairment at high doses in normoprolactinemic women; malignancy must be excluded before usage for bening breast disease; hypotensive reactions may occur (care to be exercised when driving vehicles or operating machinery); alcohol reduces tolerability; history of psychotic disorders or severe CV disease, & in acromegalic patients w/ a history or evidence of peptic ulceration.
Slight nausea, vomiting, fatigue, dizziness & orthostatic hypotension. Additionally, constipation, drowsiness, headache, confusion, psychomotor excitation, hallucinations, dyskinesia, dryness of the mouth, leg cramps & allergic skin reactions have been reported. On prolonged treatment, reversible pallor of fingers & toes have been reported.
Bromocriptine plasma levels may be increased by erythromycin or josamycin. Alcohol.

Plentiva 2.5 – 28 tab each containing natural conjugated estrogens 0.625 mg & 28 tab each containing medroxyprogesterone acetate 2.5mg. Plentive 5 – 28 tab each containing natural conjugated estrogens 0.625 mg & 28 TAB EACH CONTAINING MEDROXYPROGESTERONE ACETATE 5 MG.
Moderate-to-severe-vasomotor symptoms associated w/ estrogen deficiency, prevention & management of osteoporosis associated w/ estrogen deficiency, atrophic vaginitis & atrophic vaginitis & atrophic urethritis, beneficial effect on Total, LDL & HDL cholesterol.
Pregnancy; known or suspected cancer of the breast & estrogen dependent neoplasia; undiagnosed abnormal genital bleeding; active thrombophlebitis or thromboembolic disorders; liver dysfunction or disease.
Epilespsy, migraine, asthma, cardiac or renal dysfunction, lactation, hepatic dysfunction, surgery, endometrial hyperplasia & cancer, gall bladder disease, enlargement of pre-existing uterine fibromyomata, metabolic bone disease associated w/ hypercalcemia. Plentiva is not a contraceptive.
Nausea, abdominal cramps, edema, wt changes, breast tenderness, headache, migraine, rash, breakthough bleeding, visual disturbances, jaundice, alopecia, aggravation of porphyria.
Rifampin may reduce effectiveness.

Natural conjugated estrogens.
Osteoporosis, female hypoestrogenism, vasomotor symptoms/ Atrophic vaginitis & urethritis.
Known or suspected estrogen-dependent neoplasia. Active thrombophlebitis/ thromboembolic disorders, known or suspected breast cance. Undiagnosed abnormal genital bleeding; pregnancy.
Cardiac/renal dysfunction, increased BP, history of thromboembolic disease. Epilepsy, migraine. Asthma. Gallbladder disease, liver disorders, pancreatitis, Risk of endometrial hyperplasia or cancer, breast cancer, increase in size of pre-existing uterine leiomyomata, vag bleeding. Metabolic bone disease associated w/ hypercalcemia. Surgery. Lactation. For short-term use only. Premarin is not a contraceptive. Pre-treatment physical exam advised.
Nausea, abdominal cramps; edema, wt changes, breast changes, headache, migraine, rash, chloasma, melasma, steepening of corneal curvature, intolerance to contact lenses, changes in libido, change in menstrual flow. Vomiting, chorea, aggravation of porphyria, cholestatic jaundice, alopecia, breakthrough bleeding spotting, amenorrhea, bloating, dizziness.
Rifampicin may reduce effectiveness.

21 tab each containing- natural conjugated estrogens 0.625 mg, 10 tab each containing Medrogestone 5 mg.
Moderate to severe vasomotor symptoms associated w/ the menopause. Osteoporosis, atrophic vaginitis, atrophic urethritis. Female hypoestrogenism.
Known or suspected breast carcinoma or estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; liver dysfunction or disease; active thrombophlebitis, active thromboembolic disorders, known or suspected pregnancy.
Asthma, epilepsy, migraine, hypertension, cardiac or renal dysfunction, endometrial hyperplasia, metabolic bone disease, endometrial cancer, breast cancer, gallbladder disease, pancreatitis, lactation. Surgery, liver disorders, enlargement of uterine fibromyomata (preexisting). Prempak is not a contraceptive.
GI upsets; abdominal cramps, bloating, cholestatic jaundice, headache, migraine, dizziness, depression, breast changes, breakthrough bleeding, spotting, change in libido, chloasma, melasma, erythema multiforma, alopecia, hirsutism. Steepening of corneal curvature, intolerance to contact lenses, edema, aggravation of porphyria, erythema nodosum, hemorrhagic eruption, reduced carbohydrate tolerance. Chorea, am- enorrhea, cystitis-like syndrome, vag candidiasis, change in cervical erosion & in secretion.
Rifampicin may reduce effectiveness.

Estradiol valerate.
Climacteric complaints in the postmenopause or deficiency symptoms after oophorectomy or radiological castration for non-carcinomatous diseases, eg hot flushes, outbreaks of sweat, sleep disturbances, depressive moods, irritability, headache, dizziness.
Pregnancy; severe disturbance of liver function; jaundice or persistent itching dirung a previous; jaundice or persistent itching during a previous pregnancy; Dubin-Johnson syndrome, Rotor syndrome; previous or existing liver tumours; existing or previous thromboembolic processes; sickle-cell anaemia; existing or suspected hormone-dependent tumours of the uterus or mammae; endometriosis; severe diabetes w/ vascular changes; congenital disturbances of lipometabolism; otosclerosis w/ deterioration during pregnancy.
Close supervision in diabetes, high BP, varicose veins, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany, chorea minor, a history of phlebitis. Benign & rarely, malignant liver tumours which may lead to life-threatening intra-abdominal haemorrhage has been observed. If severe upper abdominal complaints, liver enlargement or signs of intre-abdominal haemorrhage occur, a liver tumour should be taken into consideration.
Breast tension, gastric upsets, nausea, headache, increased in body wt, uterine bleeding.
Barbiturates, phenylbutazone, hydantoins, rifampicin & ampicillin may impair the action of the drug. Requirement for oral antidiabetics & insulin can change.

Medroxyprogesterone acetate.
Secondary amenorrhoea, to produce optimum secretory transformation, abnormal uterial bleeding due to hormonal imbalance, optimum secretory transdormation.
Thrombophlebitis, thromboembolic disorders, cerebral apoplexy; liver dysfunction or disease; known or suspected malignancy of breast or genital organs; undiagnosed vag bleeding; pregnancy, missed abortion.
Epilepsy, migraine, asthma, cardiac or renal dysfunction; history of mental depression; diabetes.
nausea; fatigue, depression; acne, hirsutism; breast tenderness, galactorrhea, amenorrhea & anovulation; decreased glucose tolerance; thromboembolic phenomena; anaphylaxis; corticoid-like activity (high doses).

C) Corticosteroid Hormones

Betamethasone.
Pre-op & in serious trauma or illness, shock, as adjunctive therapy in rheumatoid disorders, ocular, dermatologic & resp allergic & inflammatory states.
Systemic fungal infection.
Discontinue treatment by reducing the dosage gradually.
Fluid & electrolyte disturbances, muscle weakness, peptic ulcer.

d) Trophic Hormones & Related Synthetic Drugs

Recombinant human somatropin.
Short stature due to inadequate or failed secretion of pituitary hormone.
Diabetes mellitus, pregnancy.
Transient local skin reactions. Occasionally, hypothyroidism.

Follitropin alfa.
Stimulation of follicular development & ovulation in women w/ hypothalamic-pituitary dysfunction who present w/ either oligomenorrhoea or amenorrhoea. Stimulation of multifollicular development in patient5 undergoing superovulation for assisted reproductive technologies.
Pregnancy, ovarian enlargement or cyst not due to polycystic ovarian disease, gynaecological haemorrhages of unknown aetiology, ovarian, uterine or mammary carcinoma, tumours of the hypothalamus & pituitary gland. When an effective response cannot be obtained, such as primary ovarian failure, malformation of sexual organs incompatible w/ pregnancy, fibroid tumours of the uterus incompatible w/ pregnancy.
Evaluate patient for hypothyroidism, adrenocortical deficiency, hyperprolactinemia & pituitary or hypothalamic tumours before starting therapy.
Fever, arthralgia, pain in the lower abdominal region, nausea, vomiting, wt gain.
Other onulation stimulating agents may potentiate the fo9llicular response whereas concurrent use of GnRH agonist-induced pituitary desensitization may increase the dosage of Gonal-F needed to elicit an adequate ovarian response.

Somatropin rDNA origin.
Long-term treatment of growth hormone deficient childn.
Subjects w/ closed epiphyses; evidence of tumor growth or ant activity of a tumour; known sensitivity to m-cresol or glycerin.
Patients w/ growth hormone deficiency secondary to an intracranial lesion should be examined frequent for progression or recurrence of the underlying disease process. Evidence of glucose intolerance should be observed. Patients w/ coexisting ACTH deficiency should have their glucocorticoid replacement dose carefully adjusted. Periodic thyroid function tests.
Antibodies to growth hormone.

Per mL Human menopausal gonadotrophin corresponding to follicle stimulating hormone (FSH) 75 iu, LH approx 75 iu.
Male Selected cases of deficient spermatogenesis. Female Infertility due to anovulation, defective follicle ripening & consequent corpus luteum insufficiency.
Ovarian, testicular & pituitary tumours.
Multiple ovulation (unwanted ovarian hyperstimulation, stop treatment). Skin rashes (rare).

Human somatropin.
Growth hormonedeficiency.
Evidence of tumour.
Diabetes mellitus, hypothyroidism, malignancy, acute leukemia, femoral capititis, antibody formation.
Concomitant glucocorticoid therapy may inhibit growth promoting effect of Norditropin.

Bromocriptine mesylate.
Prolactin-dependent menstrual cycle disorders & female infertility, polycystic ovary syndrome, supplement to anti-oestrogens in anovulatory cycles, premenstrual symptoms, male hyperprolactinaemia, prolactinomas, acromegaly, mastalgia & other forms of benign breast disease, Parkkinson’s disease.
Toxemia of pregnancy, hypertension postpartum & during puerperium.
Postpartum & puerperal women w/ high BP, coronary artery disease, or psychic disorders; concomitant use of other ergot alkaloid. Fertility may be restored (contraception needed if conception is not desired); luteal function impairment at high doses in normoprolactinemic women; malignancy must be excluded before usage for benign breast disease; hypotensive reactions may occur (care to be exercised when driving vehicles or operating machinery); alcohol reduces tolerability; history of psychotic disorders or severe CV disease, & in acromegalic patients w/ a history or evidence of peptic ulceration.
Slight nausea, vomiting, fatigue, dizziness & orthostatic hypotension. Additionally, constipation, drowsiness, headache, confusion, psychomotor excitation, hallucinations, dyskinesia, dryness of the mouth, leg cramps & allergic skin reactions have been reported. On prolonged treatment, reversible pallor of fingers & toes have been reported.
Bromocriptine plasma levels may be increased by erythromycin or josamycin. Alcohol.

HCG.
Stimulation of ovulation in anovulatory, infertile women & spermatogenesis in infertile males. Threatened & habitual abortion.
Pituitary or ovarian tumour. Prostatic carcinoma or other androgen-dependent neoplasm. Prior allergic reaction to chorionic gonadotrophin. Active thrombophlebitis.
Epilepsy, migraine, asthma, cardiac or renal disease.
Headache, irritability, restlessness, depression, fatigue, oedema, gynecomastia, pain at inj site.

Octreotide.
Acromegaly. Relief of symptoms associated w/ gastroenteropancreatic endocrine tumours. Carcinoid tumours w/ features of carcinoid syndrome, VIPomas, glucagonomas, gastrinomas/ Zollinger-Ellison syndrome, insulinomas, GRFomas. Control of refractory diarrhea associated w/ AIDs. Emergency management to stop bleeding & to protect from re-bleeding caused by gastro-oesophageal varices in patients w/ cirrhosis.
Insulinomas, diabetes, pregnancy & lactation.
Anorexia, nausea, vomiting, crampy abdominal pain, abdominal bloating, flatulence, loose stools, diarrhea, steatorrhea, rarely progressive abdominal distension, severe epigastric pain, abdominal tenderness, guarding. Impairment of post-prandial glucose tolerance, rarely: persistent hyperglycaemia. Isolated case: hepatic dysfunction. Long-term treatment:gallstones.
Reduces absorption of cimetidine.

Bromocriptine mesylate.
Galactorrhoea &/or prolactin-dependent amenorrhoea, premenstrual syndrome, short luteal phase, male hypogonadism, acromegaly.
Pregnancy.
Avoid driving vehicles or operating machinery. History of psychotic disorders, severe CV disease, peptic ulceration or GI bleeding. Acromegaly &/or pituitary adenoma.
Nausea. Rarely, vertigo or vomiting. Vasospasm, hallucinations & confusion, hypotension, dyskinesia & in Parkinsonian patients, constipation & drowsiness.
Hypotensive or psychoactive drugs.

Goserelin acetate.
Prostate cancer suitable for hormonal manipulation. Breast cancer in pre- & perimenopausal women for hormonal manipulation. Endometriosis. Endometrial thinning & uterine fibroids in conjunction w/ Fe therapy.
Pregnancy, lactation.
Patients at risk of developing ureteric obstruction or spinal cord compression. Women w/ known metabolic bone disease.
Skin rashes, generally mild. Male Hot flushes, decrease in libido. Infrequently breast swelling & tenderness. Temporary increase in bone pain. Isolated cases of ureteric obstruction & spinal cord compression recorded. Female Hot flushes, loss of libido, headache, mood changes including depression, vag dryness, change in breast size. Temporary increase in signs & symptoms. Rarely, patients w/ bony metastases have developed hypercalcaemia on initiation of therapy.

e) Anabolic Agents

Nandrolone decanoate.
Adjunct to specific therapies & dietary measures in pathologic conditions characterized by –ve nitrogen balance. Osteoporosis. Palliative treatment of selected cases of disseminated mammary carcinoma in women.
Prostatic or male mammary carcinoma; pregnancy.
Latent or overt cardiac failure, renal & hepatic dysfunction, hypertension, epilepsy, migraine, diabetes; incomplete statural growth, skeletal metastases.
High dosage or prolonged use: virilisation in women as acne; hoarseness; amenorrhea, inhibition of spermatogenesis; premature epiphyseal closure; water & salt retention.

f) Other Hormone Related Drugs

Cyproterone acetate.
Reduction of drive in sexual deviations in men, Inoperable prostatic carcinoma w/o orchiectomy, to eliminate effect of adrenocortical androgens after orchiectomy, to reduce initial increase of testosterone in treatment w/ LHRH agonists, to eliminate effect of adrenocortical androgens in treatment w/ LHRH agonists, severe signs of androgenisation in women.
Prenancy, lactation, liver disease, history of jaundice or persistent itching during previous pregnancy or a history of herpes of pregnancy; Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver tumours (in carcinoma of the prostate only if they are not due to metastases); wasting disease 9exception: prostatic carcinoma); severe chronic depression; previous or existing thromboembolic processes, severe diabetes w/ vascular changes, sickle-cell anaemia.
Diabetes. Prostatic carcinoma: careful risk-benefit- evaluation in the case of sickle-cell anaemia, severe diabetes w/ vascular changes or if there is a history of thromboembolic processes. In extremely rare cases, the occurrence of thromboembolic events has been reported. Benign & malignant liver changes have been reported in isolated cases. In very rare cases, liver tumours may lead to life-threatening intra-abdominal haemorrhage. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumours should be taken into consideration. Regular exam of liver function, adrenocortical function & RBC count. Should not be given before the conclusion of puberty. In women: if persistent or recurrent bleeding occurs during therapy, treatment must be interrupted until organic diseases have been excluded.
Inhibition of spermatogenesis (recovery usually 3-5 mth); gynaecomastia; inhibition of ovulation under the combined therapy w/ Diane-35, breast tension. Occasionally, tiredness, diminished vitality, transient inner restlessness or depressive mood, wt change. In high-dosed treatment, disturbances of liver function some of them severe; occasionally, sensation of shortness of breath; reduced adrenal cortex function.
Drive-reducing effect antagonized by alcohol. Requirement for oral antidiabetics & insulin can change.

Cyproterone acetate 2 mg, ethinylestradiol 35 µg.
Abdrogen-dependent disease in women.
Pregnancy; lactation; severe disturbances of liver function; history of idiopathic jaundice or severe pruritus during pregnancy; Dubin-Johnson syndrome, Rotor syndrome; previous or existing liver tumours; existing or previous thromboembolic processes in arteries or veins & states which predispose to such diseases; sickle-cell anaemia; existing or treated cancer of the breast or endometrium; severe diabetes w/ vascular changes; disturbances of lipometabolism; history of herpes of pregnancy, otosclerosis w/ deterioration during pregnancy.
Diabetes, hypertension, varicose veins; otosclerosis; multiple sclerosis; epilepsy; porphyria; tetany; chorea minor; history of phlebitis; cigarette smoking, age. Benign & rarely, malignant liver tumours which may lead to life-threatening intra-abdominal haemorrhage have been observed. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be taken into consideration.
Headache; gastric upsets; nausea; breast tension; changes in body wt & libido; intermenstrual bleeding; depressive moods; chloasma; rarely, poor tolerance of contact lenses.
Barbiturates, phenylbutazone, hydantoins, rifampicin & ampicillin may impair the action of the drug. Requiremnt for oral antidiabetics & insulin can change.