Trichogen Side effects

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What are the possible side effects of Trichogen?

Get emergency medical help if you have any of these signs of an allergic reaction to Trichogen: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you notice any breast lumps, pain, nipple discharge, or other breast changes. These may be signs of male breast cancer.

Less serious Trichogen side effects may include:

The sexual side effects of Trichogen (decreased libido, trouble having an erection, ejaculation problems) may continue after you stop taking this medication. Talk to your doctor if you have concerns about these side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Trichogen in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Studies for Trichogen Tablets USP 1 mg in the Treatment of Male Pattern Hair Loss

In three controlled clinical trials for Trichogen tablets USP of 12-month duration, 1.4% of patients taking Trichogen tablets USP (n=945) were discontinued due to adverse experiences that were considered to be possibly, probably or definitely drug-related (1.6% for placebo; n=934).

Clinical adverse experiences that were reported as possibly, probably or definitely drug-related in ≥1% of patients treated with Trichogen tablets USP or placebo are presented in Table 1.

TABLE 1

Drug-Related Adverse Experiences for Trichogen Tablets USP, 1 mg in Year 1 (%) MALE PATTERN HAIR LOSS

Trichogen tablets USP N=945

Placebo N=934

Decreased Libido

1.8

1.3

Erectile Dysfunction

1.3

0.7

Ejaculation Disorder (Decreased Volume of Ejaculate)

1.2

(0.8)

0.7

(0.4)

Discontinuation due to drug-related sexual adverse experiences

1.2

0.9

Integrated analysis of clinical adverse experiences showed that during treatment with Trichogen tablets USP 36 (3.8%) of 945 men had reported one or more of these adverse experiences as compared to 20 (2.1%) of 934 men treated with placebo (p=0.04). Resolution occurred in men who discontinued therapy with Trichogen tablets USP due to these side effects and in most of those who continued therapy. The incidence of each of the above adverse experiences decreased to ≤0.3% by the fifth year of treatment with Trichogen tablets USP.

In a study of Trichogen 1 mg daily in healthy men, a median decrease in ejaculate volume of 0.3 mL (-11%) compared with 0.2 mL (-8%) for placebo was observed after 48 weeks of treatment. Two other studies showed that Trichogen at 5 times the dosage of Trichogen tablets USP (5 mg daily) produced significant median decreases of approximately 0.5 mL (-25%) compared to placebo in ejaculate volume, but this was reversible after discontinuation of treatment.

In the clinical studies with Trichogen tablets USP, the incidences for breast tenderness and enlargement, hypersensitivity reactions, and testicular pain in Trichogen-treated patients were not different from those in patients treated with placebo.

Controlled Clinical Trials and Long-Term Open Extension Studies for Trichogen tablets USP, 5 mg and AVODART (dutasteride) in the Treatment of Benign Prostatic Hyperplasia

In the Trichogen tablets USP, 5 mg Long-Term Efficacy and Safety Study (PLESS), a 4-year controlled clinical study, 3040 patients between the ages of 45 and 78 with symptomatic BPH and an enlarged prostate were evaluated for safety over a period of 4 years (1524 on Trichogen tablets USP, 5 mg/day and 1516 on placebo). 3.7% (57 patients) treated with Trichogen tablets USP, 5 mg and 2.1% (32 patients) treated with placebo discontinued therapy as a result of adverse reactions related to sexual function, which are the most frequently reported adverse reactions.

Table 2 presents the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on Trichogen tablets USP, 5 mg was ≥1% and greater than placebo over the 4 years of the study. In years 2 to 4 of the study, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder.

TABLE 2

Drug-Related Adverse Experiences for Trichogen tablets USP, 5 mg

BENIGN PROSTATIC HYPERPLASIA

Year 1 (%)

Years 2, 3 and 4* (%)

Trichogen, 5 mg

Placebo

Trichogen,

5 mg

Placebo

Impotence

8.1

3.7

5.1

5.1

Decreased Libido

6.4

3.4

2.6

2.6

Decreased Volume of Ejaculate

3.7

0.8

1.5

0.5

Ejaculation Disorder

0.8

0.1

0.2

0.1

Breast Enlargement

0.5

0.1

1.8

1.1

Breast Tenderness

0.4

0.1

0.7

0.3

Rash

0.5

0.2

0.5

0.1

*Combined Years 2 to 4

N = 1524 and 1516, Trichogen vs placebo, respectively

The adverse experience profiles in the 1-year, placebo-controlled, Phase III BPH studies and the 5-year open extensions with Trichogen tablets USP, 5 mg and PLESS were similar.

There is no evidence of increased sexual adverse experiences with increased duration of treatment with Trichogen tablets USP, 5 mg. New reports of drug-related sexual adverse experiences decreased with duration of therapy.

During the 4- to 6-year placebo- and comparator-controlled Medical Therapy of Prostatic Symptoms (MTOPS) study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with Trichogen tablets USP, 5 mg but no cases in men not treated with Trichogen tablets USP, 5 mg. During the 4-year placebo-controlled PLESS study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men, but no cases were reported in men treated with Trichogen tablets USP, 5 mg.

During the 7-year placebo-controlled Prostate Cancer Prevention Trial (PCPT) that enrolled 18,882 men, there was 1 case of breast cancer in men treated with Trichogen tablets USP, 5 mg, and 1 case of breast cancer in men treated with placebo. The relationship between long-term use of Trichogen and male breast neoplasia is currently unknown.

The PCPT trial was a 7-year randomized, double-blind, placebo-controlled trial that enrolled 18,882 healthy men ≥55 years of age with a normal digital rectal examination and a PSA ≤3 ng/mL. Men received either Trichogen tablets USP, 5 mg or placebo daily. Patients were evaluated annually with PSA and digital rectal exams. Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study. The incidence of Gleason score 8 to 10 prostate cancer was higher in men treated with Trichogen (1.8%) than in those treated with placebo (1.1%). In a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor [AVODART (dutasteride)], similar results for Gleason score 8 to 10 prostate cancer were observed (1% dutasteride vs 0.5% placebo). The clinical significance of these findings with respect to use of Trichogen tablets USP, 1 mg by men is unknown.

No Clinical benefit has been demonstrated in patients with prostate cancer treated with Trichogen tablets USP, 5 mg. Trichogen tablets USP, 5 mg are not approved to reduce the risk of developing prostate cancer.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Trichogen tablets USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

Hypersensitivity Reaction:hypersensitivity reactions such as rash, pruritus, urticaria, and angioedema (including swelling of the lips, tongue, throat, and face);

Reproductive System:sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of Trichogen); testicular pain.

Neoplasms: male breast cancer;

Breast disorders: breast tenderness and enlargement;

Nervous System/Psychiatric: depression

What is the most important information I should know about Trichogen?

Trichogen contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Hypersensitivity to Trichogen or to any of the other excipients of Trichogen Sandoz.

Trichogen is for use in men only and should not be taken by women or children (<18 years). It has also been found to be ineffective in the treatment of hair loss (androgenetic alopecia) in women in clinical studies.

Trichogen should not be taken by men who are taking other medicinal product containing Trichogen, or any other 5α-reductase inhibitor for benign prostatic hyperplasia or any other condition.

Use in pregnancy & lactation: Trichogen Sandoz must not be taken by women. Women who are or may potentially be pregnant must not handle Trichogen, especially if broken or crushed. If Trichogen is absorbed through the skin or taken by mouth by women pregnant with a male foetus, the child may be born with malformed genital organs. The tablets are film-coated, which helps to prevent contact with Trichogen provided the tablets are not broken or crushed.

When the patient's sexual partner is or may become pregnant, the patient should either avoid exposure of his partner to semen (eg, by use of a condom) or discontinue treatment with Trichogen.

Ask the physician or pharmacist for advice before taking any medicine.


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References

  1. DailyMed. "FINASTERIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DTP/NCI. "98319-26-7: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "(1S,3aS,3bS,5aR,9aR,9bS,11aS)-N-tert-butyl-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Trichogen are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Trichogen. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

1 consumer reported side effects

Did you experience side effects while taking Trichogen drug?
According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Trichogen drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
Users%
No side effects1
100.0%


Consumer reviews

ERIC DELORME09 Sep 2017 01:07
french resident in philippines.was prescribe TRICHOGEN for hair thin nin g.my BPH prostate has shrunk from grade 2 to grade one recently.so b etter and asymptomatic.want to find the cheapest TRICHOGEN SCALP LOTION in philippines.


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