Prima 1000 mg Tablet 30’s Pack

Omega-6

Deficiency Induces
 Atopic & Allergic Dermatitis
 Premenstrual Syndrome
 Benign Breast Diseases & Mastalgia
 Psoriasis


Composition:
Each primal000 soft gelatin capsule contains: Evening primrose oil 1000mg. Equivalent to active ingredients GLA (Gamma Linolenic acid) 10%=100mg. And LA (Linolenic acid)72%=720mg.
Non- active ingredients & Preservative agent:
DL- Alpha tocopherol (Vita-E) 5 mg.

Introduction:
Evening primrose. Oenothera biennis is a perennial herb that takes it's name from it's unusual habit of opening it's flower between six and seven o'clock in evening. The plant is rich in an oil containing the essential unsaturated fatty acid, Gamma-Linolenic acid (GLA) of omega 6 series, is the precursor of prostaglandin E1.

Mechanism of Action:
The possible anti-inflammatory and anti-aggregatory actions of EPO may be accounted for by examining the role of GLA in eicosanoid Biochemistry. GLA is metabolized to the 20-carbon polyunsaturated fatty acid dihomo-gamma-linolenic acid (DGLA;20: 3n-6), which is a precursor to the 1-series prostaglandins, such as prostaglandin E, (PGE,). The action of PGE, on inflammatory cells (e.g., polymorphonuclear leukocytes or PMNs) is mostly inhibitory. PGE, increases intracellular cyclic AMP (cAMP). This increase reduces the release of lysosomal enzymes, PMN chemotaxis and the margination and adherence of PMNs in the blood vessels. PGE, is also thought to inhibit lymphocyte function. PGE,, in addition to its role in suppressing the inflammatory process, inhibits platelet aggregation and has vasodilatory activity. GLA, via its metabolite DGLA, has an inhibitory effect on leukotriene (LT) synthesis. Leukotrlene B4(LTB4) is an inflammatory mediator. DGLA is metabolized to 15-hydroxyl DGLA, which blocks the conversion of arachidonic acid to LTs, such as LTB4 .
In summary, GLA may suppress inflammation through its metabolism to DGLA, which, in turn, can competitively inhibit the pro-inflammatory 2-series prostaglandins and 4-series leukotrienes. The incorporation of GLA and its metabolites in cell membranes may also play a role in the possible antiinflammatory, anti-thrombotic, anti-atherogenic and anti-proliferative actions of EPO.

Indications & Usage
Dermatology:
It has been proved through well controlled clinical study that administration of Prima-1000 significantly reduced IGE (the immunoglobulin E responsible in type IV hypersensitivity reactions) in the blood and markedly redued skin lesions and Pruritis. Prima-1000 is effective in treating skin problems such as:
 Atopic and allergic Dermatitis.
 Chronic Dermatitis &Acne.
 Pruritus Racking and inflamed Eczema.
 Promotes healthy skin, nourishes brittle nail and hair.
 Psoriasis.
 Stevens Johnson Syndrome.

Dossage & Adminstration:
Atopic & Allergic Dermatitis
Adult dosages: In moderate condition 1 cap 2 times daily but in severe position dosage may be increased up to 1 cap 3/4 times daily. or as directed by the physicians.
Children dosages: The recommended daily dose of prima-1000 one cap 1/2 times daily with meals for 3/4 months or as advised by the physicians.
Stevens Johnson Syndrome: The usual dose of Prima-1000 with meal or after meal 1 Cap 2 times daily for 15 to 20 days or as advised by the physicians.
Psoriasis: Initially 1cap 2/3 times daily with or after meal. The maintenance dose is 1 cap once over a long period or as suggested by the Concerned physician.

Surgery/Gynaecology
Benign Breast diseases Mastalgia
Mastalgia (Breast pain) can be separated in two main groups
 Cyclical Mastalgia.
 Non-Cyclical Mastalgia.

Cyclical Mastalgia:
Cyclical mastalgia, as known as fibrocystic disease, cyclic mastitis and mastodyna, is a condition in which a women's breasts become painful during the week or two before her menstrual period. The discomfort is accompanid by swelling, inflammation and actual cysts that form in the breasts. It is often associated with other symptoms of premenstrual syndrome.

Non-Cyclical Mastalgia:
Non-clycal mastalgia can be divided into true breast pain arising from the ribs or chest wall. Musculoskeletal pain is common medially (Tietze's Syndrome) or laterally at edge of the breast. There are three drugs are permitted for use in benign breast disease along with mastalgia and following the responses are shown through well-control clinical trail :

The cause of mastalgia is not yet been established but researchers have found that it seems to be associated with an imbalancement of fatty acid in the body.

Premenstrual Syndrome:
It has been observed that more than 40% menstruating women are effected by premenstrual syndrome(PMS), such as abdominal bloating, Headaches, Fatigue, Fluid retention, Pelvic pain, Mood swings, Aggressions, Memory impairment, Insomnia and Anxiety etc. Prima-1000 highly effective treatment to eradicate the symptoms of PMS, were attributed to the ability of PGE1 to inhibit the affects of prolactin, an agent that responsible for premenstrual syndrome.

Dossage & Adminstration:
Benign Breast diseases & Mastalgia:
The recommended daily dose of Prima-1000 one cap 2/3 times daily with or after meal for 3/4 months for getting optimum result or as advised by the physicians.

Premenstrual Syndrome (PMS):
The recommended daily dose 1cap 2 times daily at morning and night with meal for 3/4 months or as advised by the physicians.

Adverse Reactions:
EPO may cause gastrointestinal symptoms like nausea, vomiting, flatulence, diarrhoea and bloating. Headaches have also been reported in those taking EPO. It may precipitate symptoms of undiagnosed complex partial seizures and should be used, if at all, with extreme caution in those with a history of seizure disorder or those taking drugs that lower the seizure threshold, such as aliphatic phenothiazines.

Interactions:
Drugs : Use of EPO in schizophrenics who are being treated with certain neuroleptic agents which lower seizure threshold e.g., aliphatic phenothiazines, such as chlorpromazine may cause partial complex seizures (e. g., temporal lobe epilepsy), as well as other types of seizures. Interactions may occur between EPO and warfarin, aspirin, Fish oil and NSAIDs. Such interactions, if they were to
occur, might be manifested by nosebleeds, increased susceptibility of brushing and hematuria. If these symptoms occur, EPO intake should be stopped.

Contraindication & Precautions:
Hypersensitivity to Evening Primrose Oil
Best avoided during pregnancy due to effects of hormone.
Should not be given to person with epilepsy.
Also following adverse effects have been observed through prolong used by Dr. Saiful Kabir, Asso. Prof. (Skin & VD) DNMCH
Urticaria
Prolong used, may be formed obesity (Specially for menstruating women)
Rarely found to form loose motion.

Storage:
Keep in cool preferably lower than 25'C dry place and protected from light and heat. Keep containers tightly sealed.

Presentation:
30 capsules in three blisters pack in a box
Evening primrose Oil (EPO) is approved in the United Kingdom along with some other advance Countries as a pharmaceuticals treatment for atopic dermatitis & mastalgia.

References:
1. Prostaglandis. Martindale, the extra pharmacopeia 32nd edition, 1999; 1708, 1411.

2.Prostaglandins. Remington's Pharmaceutical Sciences 18th edition, 1990; 408-410.

3. Horrobin DF The importance of gamma-linolenic acid & prostaglandin El in human nutrition & medicine. J Holistic Med 1981; 3: 118-39

4. Mills S, Bone, K. Principles and Practice of Phytotherapy : Modern Herbal Medicine. London: Churchill Livingston; 2000.

5. ABC of Breast Diseases (2nd Edition) Edited by:J.Michael Dixon. Western General Hospital, Edinburgh.

6. Horrobin D. The role of essential fatty acids and prostagandins in premenstrual syndrome. Journal of Reproductive Medicine 1983;28:465-8.

7. Stewart J, et al. Treatment of severe and moderately severe atopic darmatitis with evening primerose oil (Epogam): a multicentre study Journal of nutritional medicine 1991;2:9-15

8. Own interview of Dr. Saiful Kabir, Asso. prof. (Skin & VD), Dr. NausherAzimul Huq DNMEH and an Article written by them on 'Evening Primrose Oil in the management of Stevens Johnson Syndrome' in the Journal of Dhaka National Medical College and Hospital. (March-2005, Volume-10, November-01)