Transcript Cefanorm - AvitaFarma

Active ingredient:
Extract from Chaste tree fruits
Indication:
Menstrual disorders
Botany
Vitex agnus castus L.
Family:
Verbenaceae
(vervain plants)
Synonyms:
Monk‘s pepper
Mönchspfeffer
Abrahamsstrauch
Chaste tree
Origin:
Mediterranean area, Central Asia,
Isle Krim. Preferably also on brooksides
and riversides.
Botany
Medicinal drug: Chaste tree fruits
(Agni casti fructus),
consisting of the ripe,
dried fruits.
Brief profile

Chaste tree is a shrub up to 4 m high.

The leaves are crossed-opposite, long-stemmed.

Separated finger-shaped with up to 7 lanceolate
feathered small leaves.

The mauve, ear-like inflorescences build
reddish-black, peppercorn-sized drupes.

Time of prosperity: June to September.
Ingredients

bicyclic diterpenes (aucubin, agnoside)

lipophile flavonoids (casticin)

essential oil

fatty oil
Effects




inhibition of the prolactin secretion and thus,
reduction of increased prolactin levels
point of action at the hypophyseal portal system
dopaminergic effect
inhibition of lactation (experiments in animals)
Release and inhibition of hormones
in hormonal circuit of regulation
luteinizing hormone (LH)
follicle-stimulating
hormone (FSH)
Hypothalamus
gonadotropinreleasinghormone (GnRH)
adenohypophysis
feed-back
prolactinreleaseinhibitinghormone =
dopamine
estradiol ovary
progesterone
prolactin
stimulating influence
inhibiting influence
Quelle: PZ Nr. 10, 144 Jahrg. 1999
Fields of application
Traditional
- in the antique for women‘s diseases, especially fertility
disorders
Gynaecology
- for all symptoms of corpus luteum
insufficiency and estrogenprogesterone-imbalance
Fields of application
1. Premenstrual syndrome (PMS)
symptoms:
psychic:
nervousness, irritability, mood swings, depressive states,
lack of concentration, insomnia.
somatic:
migraine-like headache, feeling of tension in the breasts,
swellings, edema, lower abdominal cramps,
nausea, feeling of fullness, bloating,
constipation, tiredness.
Fields of application
2. Menstrual irregularities
irregularities of the menstrual rhythm
polymenorrhea/oligomenorrhea: too frequently / too rarely
irregularities of the menstrual intensity
hypomenorrhea/hypermenorrhea: too weak / too strong
irregularities of the duration of the menstruation
menorrhagia/brachymenorrhea: too long / shortened
secondary amenorrhea (absence of menstruation over a
period of 6 months, after prior normal course)
Fields of application
3. Mastodynia
premenstrual, mostly painful breast
tension, complaints are mostly
limited to the second half of the
cycle
4. Fertility disorders
Clinical efficacy
Rational phytotherapy with Vitex agnus castus
Menstrual irregularities
Increased prolactin levels, existing before start of
the therapy, could be reduced during the
treatment with Vitex agnus castus.
Roeder D, (1994): Therapy of menstrual cycle disturbances
Vitex agnus-castus. Zeitschrift für Phytotherapie 15, 155-159
Clinical efficacy
Rational phytotherapy with Vitex agnus castus
Premenstrual syndrome
The most frequent and most important symptoms such as
headache, breast tension, nervousness, lack of
concentration, emotional changes and depressions showed
a clear improvement.
Berger D, Schaffner W, Schrader E, Meier B, Brattstrom A, (2000): Efficacy of Vitex
agnus castus L. extract Ze 440 in patients with premenstrual syndrome (PMS). Arch
Gynecol Obstet. Nov; 264 (3): 150-153
Loch EG, Selle H, Boblitz N, (2000): Treatment of premenstrual syndrome with a
phytopharmaceutical formulation containing Vitex agnus castus. J Womens Health Gend
Based Med. 9 (3): 315-320
Clinical efficacy
Rational phytotherapy with Vitex agnus castus
Premenstrual syndrome
Placebo-controlled, randomised double-blind study
 The treatment of PMS with monk‘s pepper is
effective:
Significant reduction of irritability, mood swings,
aggressiveness, headache and breast tensions.
Schellenberg R, et al., (2001): Treatment for the premenstrual syndrome with
agnus castus fruit extract: prospective, randomized, placebo controlled study.
BMJ 322: 134-137
Clinical efficacy
Rational phytotherapy with Vitex agnus castus
Mastodynia
Placebo-controlled, randomised double-blind study
 Reduction of the inconvenient feeling of
tension and swelling in the breast before
menstruation
Halaska M, Beles P, Gorkow C, Sieder C, (1999): Treatment of cyclical
mastalgia with a solution containing a Vitex agnus castus extract: results of a
placebo-controlled double-blind study. Breast. 8 (4): 175-181
Clinical efficacy
Rational phytotherapy with Vitex agnus castus
Fertility disorders
Placebo-controlled, randomised double-blind study
 Duration of the luteal phases increased clearly
 Release of prolactin decreased significantly
Milewicz A, Gejdel E, Sworen H, Sienkiewicz K, Jedrzejak J, Teucher T,
Schmitz H, (1993): [Vitex agnus castus extract in the treatment of luteal phase
defects due to latent hyperprolactinemia. Results of a randomized placebocontrolled double-blind study] Arzneimittelforschung 43 (7): 752-756
Cefanorm® Advantages at a glance

normalises cycle disorders
in a natural and gentle way

stimulates corpus luteum

reduces prolactin level

does not contain any hormones
Basic information
Fields of application
Irregularities of the menstrual cycle, sensations of tension and
swelling in the breasts (mastodynia), monthly recurring complaints
before the onset of the menstruation (premenstrual symptoms).
Composition
Active ingredient:
1 capsule contains: Dry extract from Chaste tree fruits (7 - 13 : 1) 4 mg.
Extraction solvent: Ethanol 60% (m/m).
Excipients:
Glucose syrup, lactose monohydrate, talc, maize starch, magnesium stearate,
colloidal anhydrous silica, gelatin, sodium laurilsulfate (dodecylsulfate), purified
water, titanium dioxide E 171.
Basic information
Contra-indications
Cefanorm® must not be taken in when suffering from hypersensitivity to Chaste
tree fruits (Monk’s pepper) or to one of the excipients of the medicament,
hypophyseal tumours, mammary carcinoma.
Use during pregnancy and lactation: Due to not sufficient investigations
Cefanorm® must not be taken in during pregnancy and lactation.
Interactions with other substances
Interactions are not known. There are references - based on experiments in
animals - to a dopaminergic effect of the drug; thus an alternating weakening of
the effect could be possible in case of administration of dopamine-receptorantagonists.
Warning
None known.
Dosage
Intake of 1 capsule daily (corresponding to 40 mg drug).
Basic information
Kind and duration of application
Cefanorm® capsules should preferably always be taken in at the same time of day.
The preparation should be taken in over 3 menstrual cycles.
Side effects
After intake of Cefanorm® there are rarely itching rashes (urticarial exanthema).
In the leaflet, the patient is instructed to stop the intake and immediately consult
a physician in case of signs of hypersensitivity reactions.
Commercial form
Capsules: 30 pcs.
Monograph
Chaste Tree fruit, Agni casti fructus
Official Monograph of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) (German Federal
Institute for Drugs and Medical Devices)
Commission E (Phytotherapy), BAnz.-No. 226 dated December 02, 1992
Name of Drug
Agni castus fructus; chaste tree fruit, vitex fruit.
Composition of Drug
Chaste tree fruit composed of the ripe, dried fruits of Vitex agnus castus L. [Fam.
Verbenaceae], as well as their preparations in effective dosage.
Pharmacological Properties, Pharmacokinetics, Toxicology
There is evidence that aqueous-alcoholic extracts of chaste tree fruit inhibit secretion
of prolactin in vitro. In human pharmacology there are no data about the lowering of
prolactin levels. There is no knowledge regarding pharmacokinetics. Systematic
studies about toxicology are unknown.
Monograph
Clinical data
1. Uses
Irregularities of the menstrual cycle. Premenstrual complaints. Mastodynia.
Note: In case of feeling of tension and swelling of the breasts and at disturbances
of menstruation, a physician should be consulted for diagnosis.
2. Contraindications
None known.
3. Side Effects
Occasional occurrence of itching, urticarial exanthemas.
4. Special Cautions for Use
None known.
5. Use During Pregnancy and Lactation
No application during pregnancy. In animal experiments an influence on the
nursing performance was observed.
Monograph
6. Interactions with Other Drugs
Interactions are unknown. In animal experiments there is evidence
of a dopaminergic effect of the drug; therefore, a reciprocal
weakening of the effect can occur in case of ingestion of dopamine-receptor
antagonists.
7. Dosage
Unless otherwise prescribed: Daily dosage:
aqueous-alcoholic extracts corresponding to 30 - 40 mg of the drug.
8. Mode of Administration
Aqueous-alcoholic extracts (50 – 70 percent v/v) from the crushed fruits taken as
liquid or dry extract.
9. Overdosage
None known.
10. Special warnings
None known.
11. Effects on Operators of Vehicles and Machines
None known.
Differentiation in the area of
dysmenorrhoea – PMS
(Cefadian® / Cefanorm®)
Cefadian®
Cefanorm®
• girls / young women, 14- 25
• grown-up women over 25
(up to an age of 30)
• no children
• dysmenorrhoea
• (increased prostaglandin)
• does often have children
• PMS
• (imbalance estrogen/progesterone)
• most intensive on 1st day of
menstruation
• complaints during the last 10 days of
the cycle
• colic-like lower abdominal pain
• lower abdominal pain + mastodynia
general accompanying symptoms such as nausea, backache,
headache, mental depressive moods